{ "as_of": "2026-07-21T23:23:54.156813", "condition": "LLM alone: claude-haiku-4-5 with the complete benchmark corpus pasted as long context; no PortMem retrieval (track B of the original harness, run standalone)", "harness": "test_portmem_vs_llm", "n": 100, "track_b": { "currency_correct": 0.8 }, "wall_s": 114.3, "rows": [ { "pair_id": "fda_0000", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that the de" } }, { "pair_id": "fda_0001", "track_b": { "text": "# Regulatory Status: Oxymetazoline HCl\n\nBased on the FDA documents provided, **oxymetazoline HCl has a Class II recall** (Recall number: D-0623-2022). The product \"No Drip Nasal Spray, Oxymetazoline HCl 0.05%\" was recalled due to **CGMP deviations\u2014products were manufactured with contaminated excipient that was recalled from the excipient supplier.**\n\nWhile the drug label remains approved for its indicated use (temporarily relieving nasal congestion), this specific enforcement action indicates a quality/manufacturing issue rather than a safety determination about the drug itself. The recall affects particular batches, not the entire drug class.", "input_tokens": 28546, "output_tokens": 164 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0002", "track_b": { "text": "# Nelfinavir Mesylate (VIRACEPT) - Regulatory Status\n\nBased on the FDA documents provided, **nelfinavir mesylate (VIRACEPT) has a Class III recall** (Recall number: D-1443-2014). The product was recalled due to **labeling defects\u2014bottles were labeled with an incorrect expiry date of 11/2016 instead of the correct expiry date of 09/2016**.\n\nThis is a **labeling-only recall**, not a safety or efficacy issue with the drug itself. The drug label confirms it remains indicated for HIV-1 treatment in combination with other antiretroviral agents as a protease inhibitor. However, affected lots with incorrect expiration dating should not be used.", "input_tokens": 28558, "output_tokens": 172 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0003", "track_b": { "text": "# Edarbyclor (Azilsartan Kamedoxomil) Regulatory Status\n\nBased on the FDA documents provided, **Edarbyclor has been subject to an FDA enforcement action**.\n\n**Recall Details:**\n- **Product:** Edarbi (azilsartan medoxomil) tablets 80 mg\n- **Reason:** CGMP Deviations - Intermittent exposure to temperature excursion during storage\n- **Recall Number:** D-0429-2021\n- **Classification:** Class II\n\nThe drug label shows Edarbyclor is approved for treating hypertension, but the Class II recall indicates quality control issues related to improper storage conditions. A Class II recall means there is a potential health hazard but not an immediate threat to life.", "input_tokens": 28562, "output_tokens": 181 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that the drug was subject to FDA regulatory action (t" } }, { "pair_id": "fda_0004", "track_b": { "text": "# Enoxaparin Sodium Regulatory Status\n\nBased on the FDA documents provided, **Enoxaparin Sodium Injection has a Class II recall** (Recall number: D-0179-2024). The product was recalled due to **CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions** (Document 5).\n\nWhile the drug label remains approved for its indicated uses (prophylaxis of DVT, treatment of acute DVT/PE, and prophylaxis of ischemic complications), the specific recalled lot should not be used. The recall does not change the drug's overall approval status, but affected batches have been removed from distribution.", "input_tokens": 28569, "output_tokens": 152 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0005", "track_b": { "text": "# Nizatidine Regulatory Status\n\nBased on the FDA documents provided, **Nizatidine has a Class II recall** (Recall number: D-1253-2020).\n\n**Recall Reason:** CGMP Deviations - potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA in Nizatidine Oral Solution, 15 mg/mL.\n\nWhile the drug label shows Nizatidine is indicated for duodenal ulcer treatment and maintenance therapy, the recall indicates a quality/safety issue was identified with specific lots. This is a Class II recall, meaning there is a serious adverse health consequence or death possible, but it is not a complete market withdrawal (Document 6).", "input_tokens": 28561, "output_tokens": 171 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies the Class II recall and its reason (NDMA contaminatio" } }, { "pair_id": "fda_0006", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that Nortrel (norethindrone and ethinyl estradiol) ha" } }, { "pair_id": "fda_0007", "track_b": { "text": "# Regulatory Status of Fluphenazine Hydrochloride Elixir\n\nBased on the FDA documents provided, **Fluphenazine hydrochloride elixir has an approved drug label** indicating its use for management of manifestations of psychotic disorders (Document 8).\n\nHowever, **a Class II recall was issued for Haloperidol Decanoate Injection** (Document 8, Recall D-0356-2025) due to lack of assurance of sterility from bacterial contamination in media fill testing. Note that this recall applies to a different formulation (haloperidol decanoate injection) and different drug product, not the fluphenazine elixir itself.\n\n**The fluphenazine hydrochloride elixir label remains approved** with no enforcement action documented against it in these materials.", "input_tokens": 28562, "output_tokens": 191 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer fails to recognize that the quer" } }, { "pair_id": "fda_0008", "track_b": { "text": "# Regulatory Status: CABTREO (Clindamycin Phosphate/Benzoyl Peroxide/Adapalene)\n\nBased on the FDA documents provided, **CABTREO has been subject to an FDA enforcement action**. The product was recalled due to **CGMP Deviations: Product was stored outside labeled storage temperature requirements** (Recall number D-0347-2024, Class II).\n\nWhile the drug label remains approved, this Class II recall indicates a manufacturing/storage quality issue that affected product safety and efficacy. The drug itself is not withdrawn from the market, but affected lots were recalled.", "input_tokens": 28545, "output_tokens": 141 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies the FDA enforcement action (Class II recall) and expl" } }, { "pair_id": "fda_0009", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer fails to specifically identify t" } }, { "pair_id": "fda_0010", "track_b": { "text": "# Guselkumab (TREMFYA) - Regulatory Status\n\nBased on the FDA documents provided, **guselkumab has been subject to an FDA enforcement action**.\n\n**Recall Details:**\n- **Product:** Tremfya (guselkumab) Injection, 100 mg/mL\n- **Reason:** Temperature Abuse\n- **Recall Number:** D-0314-2021\n- **Classification:** Class III\n\nWhile the drug label shows guselkumab is approved for treating moderate-to-severe plaque psoriasis, active psoriatic arthritis, ulcerative colitis, and Crohn's disease in eligible patients, the Class III recall indicates that specific lots were affected by improper storage conditions. A Class III recall means there is a potential for serious adverse health consequences or death, though it is less likely than Class I or II recalls.", "input_tokens": 28569, "output_tokens": 199 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies and reports the FDA enforcement action (recall) and a" } }, { "pair_id": "fda_0011", "track_b": { "text": "# Morphine Sulfate Regulatory Status\n\nBased on the FDA documents provided, **Morphine Sulfate tablets remain approved**, but a **Class III recall was issued** for specific lots.\n\n**Recall Details:**\n- **Product:** Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles\n- **Reason:** Failed Impurities/Degradation Specifications\n- **Recall Number:** D-1245-2019\n- **Classification:** Class III\n\nThe drug label confirms morphine sulfate tablets are indicated for management of acute and chronic pain in adults and pediatric patients weighing at least 50 kg as you described. However, the Class III recall indicates that certain manufacturing batches failed quality specifications for impurities/degradation, meaning those specific lots should not be used. The drug itself remains FDA-approved, but affected batches were recalled due to quality control failures.", "input_tokens": 28560, "output_tokens": 205 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Justification:**\n\n- **currency_correct=1**: The answer correctly identifies and men" } }, { "pair_id": "fda_0012", "track_b": { "text": "# Buprenorphine Hydrochloride Regulatory Status\n\nBased on the FDA documents provided, **Buprenorphine Hydrochloride sublingual tablets remain approved**, but a **Class II recall was issued** for the Belbuca formulation (buprenorphine hydrochloride buccal film 300 mcg) due to CGMP deviations involving temperature excursion during storage (Recall D-0448-2021).\n\nThe drug label confirms buprenorphine sublingual tablets are indicated for opioid dependence treatment as part of a complete treatment plan including counseling and psychosocial support. However, the recall means affected batches of the buccal film formulation should not be used.", "input_tokens": 28557, "output_tokens": 167 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Justification:**\n\n- **currency_correct=1**: The answer correctly identifies that a " } }, { "pair_id": "fda_0013", "track_b": { "text": "# Regulatory Status Response\n\nBased on the FDA documents provided, I cannot definitively answer your question because it is incomplete. Your question asks about a drug \"indicated for the following\" and \"should be used only to treat or prevent in?\" but the indication is cut off.\n\nHowever, if you're asking about **Cefdinir** (Document 14), which has this exact language in its label about reducing drug-resistant bacteria: **Cefdinir was recalled** (Recall D-0375-2019, Class II) due to CGMP deviations\u2014the reconstituted suspension was observed to be thick. The drug itself remains approved, but this specific product batch had quality issues.\n\nPlease clarify which drug you're asking about so I can provide a complete answer regarding its current approval status and any enforcement actions.", "input_tokens": 28552, "output_tokens": 179 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that Cefdin" } }, { "pair_id": "fda_0014", "track_b": { "text": "# Ondansetron Regulatory Status\n\nBased on the FDA documents provided, **Ondansetron tablets remain approved** for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin \u226550 mg/m\u00b2.\n\nHowever, there **was an FDA enforcement action**: Ondansetron Injection, USP (4mg/2mL) was recalled in 2013 (Recall D-851-2013, Class II) due to the presence of particulate matter in certain lots. This recall applied specifically to the injectable formulation, not the tablets indicated for chemotherapy-related nausea.\n\nThe drug label remains in effect, and the tablet formulation for this indication has not been suspended or withdrawn.", "input_tokens": 28559, "output_tokens": 171 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that there " } }, { "pair_id": "fda_0015", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that bisoprolol fumarate and hydrochlorothiazide had " } }, { "pair_id": "fda_0016", "track_b": { "text": "# Cathflo\u00ae Activase\u00ae (Alteplase) Regulatory Status\n\nBased on the FDA documents provided, **Cathflo\u00ae Activase\u00ae (Alteplase) has a Class II recall** (Recall number: D-0509-2024) due to **lack of assurance of sterility\u2014deformed stoppers were observed during filling operations**. \n\nThe drug label remains approved for its indicated use (restoration of function to central venous access devices), but this specific recall means affected batches should not be used. The recall does not change the drug's overall approval status, only the safety of particular lots.", "input_tokens": 28554, "output_tokens": 141 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0017", "track_b": { "text": "# Testosterone Regulatory Status\n\nBased on the FDA documents provided, **Testosterone has a Class III recall** (Recall number D-1010-2019) for Testosterone Topical Solution due to a **defective container** \u2014 specifically, repetitive complaints that the pump was not working.\n\nHowever, this is a **product-specific recall**, not a suspension or withdrawal of the drug class itself. The drug label shows Testosterone is still approved for the indicated uses you mentioned, including replacement therapy for primary hypogonadism and other conditions associated with testosterone deficiency in males. The recall affects only specific batches of the topical solution formulation with defective delivery systems, not the drug's approval status overall.", "input_tokens": 28558, "output_tokens": 154 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0018", "track_b": { "text": "# Simvastatin Regulatory Status\n\nBased on the FDA documents provided, **Simvastatin tablets USP** (indicated to reduce risk of coronary heart disease death, non-fatal myocardial infarction, and stroke) has a **Class III recall** in effect.\n\n**Recall Details:**\n- **Product:** Simvastatin Tablets, USP 40 mg, 1000-count bottles\n- **Reason:** Labeling defect\u2014bottles labeled with incorrect lot number (05318054B instead of 05318034B)\n- **Recall Number:** D-1842-2019\n- **Classification:** Class III\n\nThe drug itself remains approved, but this specific lot has a labeling recall that affects its distribution and use. (Document 19)", "input_tokens": 28561, "output_tokens": 178 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Justification:**\n\n- **currency_correct=1**: The answer correctly identifies and men" } }, { "pair_id": "fda_0019", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that diclofenac sodium and misoprostol had a Class II" } }, { "pair_id": "fda_0020", "track_b": { "text": "# Cetirizine Regulatory Status\n\nBased on the FDA documents provided, **Cetirizine Hydrochloride has been recalled**. \n\nThe drug was subject to an FDA Drug Enforcement Action (Recall number D-0348-2025, Class II) due to **CGMP Deviations**. The recalled product was Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, manufactured for Glenmark Therapeutics Inc. and distributed by Amazon (NDC# 72657-129-35).\n\nWhile the drug label remains approved for temporarily relieving hay fever and upper respiratory allergy symptoms, this specific recall indicates quality control issues that affected the product's safety status at the time of the enforcement action.", "input_tokens": 28554, "output_tokens": 176 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Justification:**\n\n- **currency_correct=1**: The answer correctly identifies and men" } }, { "pair_id": "fda_0021", "track_b": { "text": "# Regulatory Status: Timolol (Dorzolamide/Timolol Ophthalmic Solution)\n\nBased on the FDA documents provided, **Timolol has an active recall** that affects its safety status.\n\n**Recall Details:**\n- **Product:** Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles\n- **Reason:** Lack of Assurance of Sterility - out of specification for volume and compromised container closure\n- **Recall Number:** D-0374-2024\n- **Classification:** Class II\n\nWhile the drug label shows timolol is indicated for reducing elevated intraocular pressure in open-angle glaucoma patients, the Class II recall means the affected lots pose a potential health hazard and should not be used. Patients should verify their product lot numbers against FDA recall notices.", "input_tokens": 28566, "output_tokens": 198 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies and emphasizes the FDA recall action (Class II), spec" } }, { "pair_id": "fda_0022", "track_b": { "text": "# Iclevia (Levonorgestrel and Ethinyl Estradiol)\n\nBased on the FDA documents provided, **Iclevia has an approved drug label** indicating it is a combination oral contraceptive for pregnancy prevention in females of reproductive potential. However, **no FDA enforcement action or recall is listed for Iclevia itself** in these documents.\n\nThe document shows only the drug label without any recall, suspension, or enforcement action against this product.", "input_tokens": 28566, "output_tokens": 105 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer states \"no FDA enforcement actio" } }, { "pair_id": "fda_0023", "track_b": { "text": "# Acetaminophen Regulatory Status\n\nBased on the FDA documents provided, **Acetaminophen has an approved drug label** indicating it is indicated for temporarily relieving minor aches and pains (headache, common cold, backache, arthritis pain, toothache, muscular aches, menstrual cramps) and temporarily reducing fever.\n\nHowever, **a Class II recall was issued** (Recall D-0601-2022) for Acetaminophen Child Bubble Gum Flavored Oral Suspension due to CGMP deviations\u2014the product was manufactured with a contaminated excipient that was recalled from the excipient supplier. This recall applies to that specific formulation, not the drug itself.", "input_tokens": 28562, "output_tokens": 165 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that a Class II recall was issued for a specific acet" } }, { "pair_id": "fda_0024", "track_b": { "text": "# Gabapentin Regulatory Status\n\nBased on the FDA documents provided, **Gabapentin Capsules, USP has a Class II recall** (Recall number D-0375-2019). The product was recalled due to **Failed Capsule/Tablet Specifications** \u2014 specifically, complaints of clumping and breaking of capsules, with some bottles showing popped-out bottoms and creased labels.\n\n**The drug label remains approved** for the indicated uses (postherpetic neuralgia and adjunctive seizure therapy), but this specific recalled batch should not be used due to the manufacturing defect affecting capsule integrity.", "input_tokens": 28562, "output_tokens": 142 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that there " } }, { "pair_id": "fda_0025", "track_b": { "text": "# Azacitidine for Injection\n\nBased on the FDA documents provided, **azacitidine for injection has a Class III recall** (Recall number D-1334-2022). The product was recalled due to being **subpotent** \u2014 out of specification results were obtained during a stability study for Assay, with results below specification.\n\nWhile the drug label shows it remains indicated for treating myelodysplastic syndrome (MDS), the recall means affected lots do not meet quality standards and should not be used. The drug itself is still approved, but specific recalled batches are unsafe due to insufficient active ingredient potency.", "input_tokens": 28564, "output_tokens": 141 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies and mentions the Class III recall with specific detai" } }, { "pair_id": "fda_0026", "track_b": { "text": "# Fluoxetine Regulatory Status\n\nBased on the FDA documents provided, **Fluoxetine has been subject to an FDA enforcement action**.\n\n**Recall Details:**\n- **Product:** Fluoxetine Capsules USP, 20 mg (500-count and 1000-count bottles)\n- **Reason:** Chemical Contamination - elevated level of residual solvent impurity in the API exceeding the Threshold of Toxicological Concern (TTC)\n- **Recall Number:** D-0971-2015\n- **Classification:** Class II\n\nThe drug label remains approved for the indicated uses (Major Depressive Disorder, OCD, Bulimia Nervosa, Panic Disorder, etc.), but specific lots were recalled due to manufacturing quality issues. The recall was issued in 2015 and was limited to contaminated batches rather than a blanket suspension of the drug.", "input_tokens": 28560, "output_tokens": 207 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and describ" } }, { "pair_id": "fda_0027", "track_b": { "text": "# Dapsone Regulatory Status\n\nBased on the FDA documents provided, **Dapsone has an active recall** for the product **Dapsone Gel 7.5%** (Document 28). The recall reason is **Crystallization** (Recall number D-0038-2025, Classification: Class II).\n\nHowever, this recall applies specifically to the gel formulation. The drug label indicates Dapsone tablets remain approved for the indications you mentioned: dermatitis herpetiformis and leprosy. The crystallization issue in the gel formulation does not necessarily affect the safety or approval status of other Dapsone formulations, but patients should verify they are not using the recalled gel product.", "input_tokens": 28552, "output_tokens": 160 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0028", "track_b": { "text": "# Paroxetine Hydrochloride - Regulatory Status\n\nBased on the FDA documents provided, **Paroxetine Hydrochloride tablets have a Class II recall** (Recall number D-0121-2024). The product was recalled due to **Failed Impurities/Degradation Specifications\u2014out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine** in 30 mg tablets from multiple manufacturers.\n\nWhile the drug label remains approved for the indications you listed (MDD, OCD, PD, SAD, GAD, PTSD), the recall indicates a quality/manufacturing issue with certain batches rather than a safety concern with the drug itself. The Class II classification means there is a potential health hazard but not an immediate threat to life.", "input_tokens": 28563, "output_tokens": 186 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0029", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that valsartan and hydrochlorothiazide had a Class II" } }, { "pair_id": "fda_0030", "track_b": { "text": "# Albuterol Sulfate HFA Regulatory Status\n\nBased on the FDA documents provided, **Albuterol Sulfate HFA has a Class II recall** (Recall number D-1666-2012). The product was recalled because it **does not deliver the proper metered dose\u2014the potential content of albuterol per dose is below specification** (Document 31).\n\nWhile the drug label remains approved for its indicated uses (treatment or prevention of bronchospasm), this recall indicates a safety and efficacy concern with specific batches of the Ventolin HFA formulation. Patients should verify their product is not part of the recalled lot.", "input_tokens": 28568, "output_tokens": 147 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Justification:**\n\n- **currency_correct=1**: The answer correctly identifies and men" } }, { "pair_id": "fda_0031", "track_b": { "text": "# Phenytoin Sodium Regulatory Status\n\nBased on the FDA documents provided, **Extended Phenytoin Sodium Capsules, USP 100 mg had a Class II recall** (Recall number D-0876-2023) due to **failed dissolution specifications** with out-of-specification results above specification limits.\n\nThis recall indicates a quality/manufacturing issue with that specific product lot, not a withdrawal of approval for the drug itself. The drug label remains approved for its indicated uses, including treatment of generalized tonic-clonic status epilepticus and seizure prevention during neurosurgery. However, affected batches should not be used due to the dissolution failure.", "input_tokens": 28558, "output_tokens": 149 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies the Class II recall and its reason (failed dissolutio" } }, { "pair_id": "fda_0032", "track_b": { "text": "# Hetastarch (6% in 0.9% Sodium Chloride Injection)\n\nBased on the FDA documents provided, **a recall has been issued for this drug**.\n\n**Hetastarch Injection (HEXTEND)** was subject to an FDA enforcement action:\n- **Recall Number:** D-184-2013\n- **Classification:** Class II\n- **Reason:** Lack of Assurance of Sterility - potential for solution to leak from the seal of the fill tube to the bag\n\nThe drug label shows the product is approved for the indicated uses (hypovolemia treatment and leukapheresis), but the recall means specific lots had sterility concerns and should not be used. (Document 33)", "input_tokens": 28564, "output_tokens": 165 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that a recall was issued (D-184-2013, Class II) and s" } }, { "pair_id": "fda_0033", "track_b": { "text": "# Rimegepant Sulfate (NURTEC ODT)\n\nBased on the FDA documents provided, **rimegepant sulfate (NURTEC ODT) has a Class II recall**, not a suspension or withdrawal of approval.\n\n**Recall Details:**\n- **Product:** NURTEC ODT (Rimegepant) 75MG\n- **Reason:** CGMP Deviations - Intermittent exposure to temperature excursion during storage\n- **Recall Number:** D-0451-2021\n- **Classification:** Class II\n\nThe drug remains FDA-approved; however, affected batches were recalled due to storage temperature violations. The drug itself is still indicated for acute treatment of migraine with or without aura and preventive treatment of episodic migraine in adults, as stated in the label (Document 34).", "input_tokens": 28564, "output_tokens": 193 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0034", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer fails to identify that velpatasv" } }, { "pair_id": "fda_0035", "track_b": { "text": "# Lorazepam Regulatory Status\n\nBased on the FDA documents provided, **only a drug label is present for Lorazepam with no enforcement action mentioned**. The label indicates Lorazepam is indicated for management of anxiety disorders and short-term relief of anxiety symptoms (Document 36).\n\nHowever, I should note that Document 36's label text appears to be mislabeled\u2014it discusses Lorazepam indications but is filed under \"NOREPINEPHRINE BITARTRATE\" with a recall for Levophed (norepinephrine bitartrate). This labeling inconsistency in the provided documents prevents me from making a definitive statement about Lorazepam's current approval status based solely on these materials.", "input_tokens": 28555, "output_tokens": 166 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that there " } }, { "pair_id": "fda_0036", "track_b": { "text": "# Regulatory Status of Ofloxacin Ophthalmic Solution\n\nBased on the FDA documents provided, **only a drug label is present for Ofloxacin ophthalmic solution with no enforcement action listed**. The label indicates it is indicated for treatment of infections caused by susceptible bacteria. However, the document provided appears under the Azelaic Acid entry (Document 37), suggesting a potential labeling discrepancy in the source material.\n\n**No recall, suspension, or enforcement action is documented for Ofloxacin ophthalmic solution in these materials.**", "input_tokens": 28552, "output_tokens": 131 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer fails to acknowledge the FDA enf" } }, { "pair_id": "fda_0037", "track_b": { "text": "# Candesartan Cilexetil - Regulatory Status\n\nBased on the FDA documents provided, **Candesartan Cilexetil Tablets have been subject to an FDA enforcement action**.\n\n**Recall Details:**\n- **Product:** Candesartan Cilexetil Tablets, USP 16 mg\n- **Reason:** Failed Impurities/Degradation Specifications; out of specification for Related Compound\n- **Recall Number:** D-0798-2021\n- **Classification:** Class III\n\nWhile the drug label shows it is indicated for treatment of hypertension and heart failure, the Class III recall indicates a manufacturing/quality issue was identified. This means the drug itself remains approved, but specific lots were recalled due to impurity concerns.", "input_tokens": 28571, "output_tokens": 175 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that the drug was subject to FDA regulatory action (t" } }, { "pair_id": "fda_0038", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that ezetim" } }, { "pair_id": "fda_0039", "track_b": { "text": "# Regulatory Status Response\n\nBased on the documents provided, **Hydroxyzine Pamoate** (matching your indications for anxiety and tension relief) has a **Class II recall** on file.\n\n**FDA Drug Enforcement Action Details:**\n- **Product:** Teva Hydroxyzine Pamoate Capsules, USP, 100 mg\n- **Reason for Recall:** CGMP Deviations - Hydroxyzine Pamoate Capsules were manufactured using an unapproved material; API was incorrectly released for use in manufacturing\n- **Recall Number:** D-1093-2014\n- **Classification:** Class II\n\nThe drug label remains approved, but this manufacturing deviation recall indicates quality control issues with specific lots. The drug class itself is not suspended, but affected batches were recalled due to GMP violations.", "input_tokens": 28557, "output_tokens": 191 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that there " } }, { "pair_id": "fda_0040", "track_b": { "text": "# Naproxen Regulatory Status\n\nBased on the FDA documents provided, **only a drug label is present for Naproxen** \u2014 no enforcement action, recall, suspension, or other regulatory action is documented. The label indicates Naproxen tablets and naproxen sodium tablets are indicated for relief of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and other conditions as stated.\n\n**The drug remains approved with no documented FDA enforcement action affecting its status.**", "input_tokens": 28572, "output_tokens": 114 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Explanation:**\n\n- **currency_correct=0**: The answer fails to mention the FDA enfor" } }, { "pair_id": "fda_0041", "track_b": { "text": "# Posaconazole Regulatory Status\n\nBased on the FDA documents provided, **posaconazole (an azole antifungal) has a Class II recall** and is not simply \"currently approved and safe.\"\n\n**Recall Details:**\n- **Product:** Posaconazole Delayed-Release Tablets, 100 mg\n- **Reason:** Failed Impurities/Degradation Specifications with high out-of-specification degradation results\n- **Recall Number:** D-0268-2023\n- **Classification:** Class II\n\nThe drug label remains approved for its indicated uses (prophylaxis of invasive Aspergillus and Candida infections in immunocompromised patients), but specific lots have been recalled due to quality failures. The approval status has been affected by this enforcement action.", "input_tokens": 28564, "output_tokens": 185 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies the Class II recall and its reason (failed impurities" } }, { "pair_id": "fda_0042", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\nThe answer fails to address the specific drug in question (brimonidin" } }, { "pair_id": "fda_0043", "track_b": { "text": "# Regulatory Status of MAXALT (Rizatriptan)\n\nBased on the FDA documents provided, **MAXALT has a Class III recall** (Recall number: D-0078-2022). \n\nThe recall was issued for **Rizatriptan Benzoate Film Coated Tablets, 10 mg** due to **out-of-specification test results obtained in the Organic Impurities test** during analysis of controlled samples.\n\nWhile the drug label remains approved for the indicated use (acute treatment of migraine with or without aura in adults and pediatric patients 6-17 years old), this Class III enforcement action indicates a regulatory concern affecting certain lots of the product.", "input_tokens": 28573, "output_tokens": 157 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies the Class III recall and the specific reason (out-of-" } }, { "pair_id": "fda_0044", "track_b": { "text": "# Promethazine Hydrochloride - Regulatory Status\n\nBased on the FDA documents provided, **Promethazine Hydrochloride has a Class II recall** (Recall number D-1342-2014). The product was recalled due to **presence of foreign tablets\u2014atenolol 25 mg tablets were mixed into promethazine 25 mg tablet bottles**.\n\nThis is a manufacturing/packaging error recall, not a safety issue with the drug itself. The drug label remains approved for the indications you listed (perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, and mild allergic skin manifestations). However, affected lots from that recall should not be used.", "input_tokens": 28568, "output_tokens": 163 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0045", "track_b": { "text": "# Verapamil Hydrochloride - Regulatory Status\n\nBased on the FDA documents provided, **Verapamil Hydrochloride tablets remain approved** for the treatment of angina (including vasospastic and unstable angina). However, **an FDA enforcement action has been issued** for a specific Verapamil Hydrochloride Injection product.\n\n**Enforcement Action Details:**\n- **Product:** Verapamil Hydrochloride Injection, USP 5 mg/2mL\n- **Reason for Recall:** Cross contamination with other products\n- **Recall Number:** D-0592-2024\n- **Classification:** Class III\n\nThe recall applies to the injectable formulation due to cross-contamination concerns, not the oral tablets indicated for angina. The drug label for the tablet formulation remains in effect.", "input_tokens": 28572, "output_tokens": 195 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Justification:**\n\n- **currency_correct=1**: The answer correctly identifies that an" } }, { "pair_id": "fda_0046", "track_b": { "text": "# Cefazolin Sodium\n\nBased on the FDA documents provided, **Cefazolin for Injection, USP has been subject to a Class II recall** (Recall number: D-1118-2022) due to cGMP deviations involving temperature abuse during storage. \n\nWhile the drug label indicates it is approved for treating serious infections including respiratory tract infections, the recall means affected batches should not be used. The drug itself remains approved, but specific lots were recalled for quality/storage condition violations.", "input_tokens": 28561, "output_tokens": 115 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that the dr" } }, { "pair_id": "fda_0047", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\nThe answer fails to address the specific drug in question (NeoRelief " } }, { "pair_id": "fda_0048", "track_b": { "text": "# Capecitabine Regulatory Status\n\nBased on the FDA documents provided, **Capecitabine tablets (a nucleoside metabolic inhibitor for colorectal cancer) has been subject to an FDA enforcement action**.\n\n**Recall Details:**\n- **Product:** Capecitabine tablets USP 500 mg\n- **Reason:** Failed Dissolution Specifications (low test results at 18-month time-point)\n- **Recall Number:** D-0732-2016\n- **Classification:** Class II\n\nThe drug label remains approved, but this Class II recall indicates quality control issues with specific lots. The drug itself is still approved for use, but affected batches were recalled due to dissolution failures that could impact drug efficacy. (Document 49)", "input_tokens": 28562, "output_tokens": 173 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that the drug was subject to FDA regulatory action (t" } }, { "pair_id": "fda_0049", "track_b": { "text": "# Methylphenidate Hydrochloride Extended-Release Capsules\n\nBased on the FDA documents provided, **methylphenidate hydrochloride extended-release capsules for ADHD treatment in pediatric patients 6-12 years of age remain approved**, but there has been an FDA enforcement action.\n\n**Enforcement Action:** A Class II recall was issued for **Daytrana (methylphenidate transdermal system)** patches (Recall D-0429-2017) due to defective delivery system with out-of-specification mechanical peel force results. However, this recall applies specifically to the transdermal patch formulation, not the oral extended-release capsules.\n\nThe drug label confirms the indication you referenced is valid. The enforcement action does not appear to have suspended or withdrawn approval for the drug class itself, though the specific product formulation recalled should be avoided.", "input_tokens": 28567, "output_tokens": 195 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that there " } }, { "pair_id": "fda_0050", "track_b": { "text": "# Regulatory Status Response\n\nBased on the FDA documents provided, **Doxycycline Hyclate** (the drug matching your indication about reducing drug-resistant bacteria) has a **Class II recall** on file.\n\n**Recall Details:**\n- **Product:** Doxycycline Hyclate Tablets USP, 100 mg\n- **Reason:** Failed dissolution specification\u2014out of specification results at the 24-month time point (end of shelf life)\n- **Recall Number:** D-1274-2020\n- **Classification:** Class II\n\nThe drug label remains approved, but affected batches were recalled due to dissolution failures that could impact drug effectiveness. (Document 51)", "input_tokens": 28552, "output_tokens": 158 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Justification:**\n- **currency_correct=1**: The answer correctly identifies and ment" } }, { "pair_id": "fda_0051", "track_b": { "text": "# Regulatory Status for First Aid Antiseptic Products\n\nBased on the FDA documents provided, there are **two drugs with this indication that have been recalled**:\n\n1. **Povidone-Iodine (First Aid Antiseptic Ointment)** - Recalled due to incorrect/undeclared excipients (Document 52, Recall D-0013-2025, Class II)\n\n2. **Pro Numb Tattoo Numbing Spray (5% Lidocaine)** - Recalled due to cGMP deviations (Document 72, Recall D-0302-2026, Class II)\n\nThese recalls indicate that while the drug class may be approved, specific product formulations have been removed from the market due to manufacturing or labeling issues. The recalls do not necessarily mean the drug indication itself is unsafe, but rather that these particular products failed to meet FDA standards.", "input_tokens": 28531, "output_tokens": 204 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that the povidone-iodine product was subject to FDA r" } }, { "pair_id": "fda_0052", "track_b": { "text": "# Hydromorphone Hydrochloride Regulatory Status\n\nBased on the FDA documents provided, **Hydromorphone Hydrochloride tablets and oral solution remain approved**, but a **Class II recall was issued** (Recall D-0448-2021) for Hydromorphone Hydrochloride Injection due to temperature excursion during storage.\n\nThe recall applies specifically to the **injection formulation**, not the oral tablets or oral solution you referenced. The oral formulations' approval status has not been changed by enforcement action in these documents\u2014only a drug label is present for the oral forms.", "input_tokens": 28555, "output_tokens": 133 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer states the drug \"remains approve" } }, { "pair_id": "fda_0053", "track_b": { "text": "# Levothyroxine Sodium - Regulatory Status\n\nBased on the FDA documents provided, **Levothyroxine Sodium tablets for hypothyroidism have a Class II recall** (Recall D-0120-2025). The product was recalled due to **potency failures** - both superpotent and subpotent drug results were obtained in 150 mcg tablets manufactured by Mylan Pharmaceuticals.\n\nWhile the drug label remains approved for hypothyroidism treatment, this enforcement action indicates quality control issues affecting the safety and efficacy of specific lots. The drug class itself is not suspended, but affected batches should not be used.", "input_tokens": 28562, "output_tokens": 146 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0054", "track_b": { "text": "# Clonidine Hydrochloride Regulatory Status\n\nBased on the FDA documents provided, **Clonidine Hydrochloride tablets remain approved** with an active drug label indicating they are indicated for the treatment of hypertension and may be used alone or with other antihypertensive agents.\n\nHowever, there is an **FDA enforcement action** on record: Duraclon (clonidine HCl injection) was recalled due to cGMP deviations from temperature abuse (Recall D-1091-2022, Class II). This recall applies specifically to the **injection formulation**, not the oral tablets.\n\nThe oral tablet formulation's approval status has not been changed by enforcement action in these documents.", "input_tokens": 28549, "output_tokens": 162 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0055", "track_b": { "text": "# Liothyronine Sodium Regulatory Status\n\nBased on the FDA documents provided, **Liothyronine Sodium tablets have been recalled**. \n\nA Class II recall (D-0150-2024) was issued for Liothyronine Sodium Tablets, USP 5 mcg due to **Failed Impurities/Degradation Specifications**. The product was distributed by Sun Pharmaceutical Industries, Inc.\n\nWhile the drug label remains approved for hypothyroidism treatment, this specific recall indicates a quality/safety issue with certain batches that affected the drug's current market availability.", "input_tokens": 28573, "output_tokens": 138 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that the drug was subject to FDA regulatory action (t" } }, { "pair_id": "fda_0056", "track_b": { "text": "# Moxifloxacin Regulatory Status\n\nBased on the FDA documents provided, **Moxifloxacin tablets remain approved**, but a **Class III recall was issued** (Recall D-1050-2018) for Moxifloxacin Ophthalmic Solution due to failed impurities/degradation specifications with out-of-specification results in the related substance test during stability studies.\n\nThe recall applies specifically to the **ophthalmic (eye drop) formulation**, not the oral tablet formulation indicated for treating infections in adults. The drug label for moxifloxacin tablets remains in effect for its approved indications.", "input_tokens": 28558, "output_tokens": 150 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that a Clas" } }, { "pair_id": "fda_0057", "track_b": { "text": "# Risedronate Sodium - Regulatory Status\n\nBased on the FDA documents provided, **Risedronate Sodium delayed-release tablets have been subject to an FDA enforcement action**.\n\nThe product was **recalled** (Recall number D-0762-2022, Classification: Class III) due to **Failed Content Uniformity Specifications**. The recalled product was Risedronate Sodium Tablets, USP, 5 mg, manufactured for Macleods Pharma USA.\n\nWhile the drug label remains approved for treatment of postmenopausal osteoporosis, this specific recall indicates quality control issues with certain lots. Patients should verify their medication source and consult their healthcare provider if they have concerns about their risedronate supply.", "input_tokens": 28566, "output_tokens": 169 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that the drug was subject to FDA regulatory action (t" } }, { "pair_id": "fda_0058", "track_b": { "text": "# Clotrimazole Regulatory Status\n\nBased on the FDA documents provided, **Clotrimazole has a Class II recall** (Recall number D-0154-2021). \n\nThe product was recalled due to **Failed Impurities/Degradation Specifications**: an unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.\n\nWhile the drug label remains approved for treating athlete's foot, jock itch, and ringworm, the recall indicates a quality/safety issue with specific lots of the product. The drug itself is not suspended or withdrawn from the market, but affected batches should not be used.", "input_tokens": 28572, "output_tokens": 153 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0059", "track_b": { "text": "# Atomoxetine (ADHD Treatment)\n\n**Status:** The drug has a **Class II recall** in effect.\n\n**Details:** Atomoxetine Capsules, USP 80 mg were recalled (Recall #D-0236-2025) due to **CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.** While the drug label remains approved for ADHD treatment, this specific product batch has been removed from distribution due to quality control issues.\n\nThe drug itself is still FDA-approved for its indicated use, but affected batches should not be used.", "input_tokens": 28577, "output_tokens": 148 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0060", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that irbesartan/hydrochlorothiazide had a Class II re" } }, { "pair_id": "fda_0061", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer fails to specifically identify t" } }, { "pair_id": "fda_0062", "track_b": { "text": "# Ibuprofen Regulatory Status\n\nBased on the FDA documents provided, **Ibuprofen has been subject to an FDA enforcement action**. \n\nThe drug label shows Ibuprofen Tablets USP 200 mg are indicated for temporarily relieving minor aches and pains (headache, toothache, backache, menstrual cramps, common cold, muscular aches, minor pain of arthritis) and temporarily reducing fever. However, there is a **Class II recall** (Recall number D-0583-2018) for Ibuprofen Tablets USP 200 mg, 100-count bottles distributed by Spirit Pharmaceuticals, LLC, due to CGMP deviations in response to a previous recall.", "input_tokens": 28559, "output_tokens": 169 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer explicitly mentions the Class II" } }, { "pair_id": "fda_0063", "track_b": { "text": "# Desoximetasone Regulatory Status\n\nBased on the FDA documents provided, **Desoximetasone cream USP (0.05% and 0.25%) and gel USP (0.05%)** had a **Class II recall** (Recall number D-0116-2017) due to failed stability specifications\u2014the affected lots exhibited out-of-specification results for the homogeneity test showing moderate separation.\n\nHowever, this was a **specific lot recall**, not a suspension or withdrawal of the drug from the market. The drug label remains approved for its indicated use in relieving inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The recall addressed manufacturing quality issues in particular batches, not the safety or efficacy of the drug itself.", "input_tokens": 28571, "output_tokens": 173 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0064", "track_b": { "text": "# Dofetilide (TIKOSYN) Regulatory Status\n\nBased on the FDA documents provided, **dofetilide (TIKOSYN) has been subject to an FDA enforcement action**. \n\nA Class II recall was issued (Recall number D-0384-2023) for Dofetilide Capsules 250 mcg due to **CGMP Deviations following an FDA inspection**. The drug label remains approved for its indicated use in maintenance of normal sinus rhythm in atrial fibrillation/flutter patients, but the specific recalled lots are no longer safe for distribution.", "input_tokens": 28567, "output_tokens": 139 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that dofetilide was subject to FDA regulatory action " } }, { "pair_id": "fda_0065", "track_b": { "text": "# Regulatory Status Response\n\nBased on the FDA documents provided, I cannot identify a drug with the indication \"Multi-purpose mineral powder provides broad-spectrum SPF 46 PA+++ protection. Leaves the skin flawless and protected.\"\n\nThis indication appears in two documents (Documents 66 and 67) but appears to be **mislabeled or incorrectly paired** with those drug labels:\n- Document 66 is for **Delflex Peritoneal Dialysis Solution** (a dialysis product)\n- Document 67 is for **Atorvastatin Calcium** (a cholesterol-lowering medication)\n\nNeither of these drugs are sunscreen or cosmetic products. If you're asking about a specific sunscreen product, please provide the correct drug name or active ingredient, and I can search the enforcement actions accordingly.", "input_tokens": 28547, "output_tokens": 188 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that there " } }, { "pair_id": "fda_0066", "track_b": { "text": "# Regulatory Status Response\n\nBased on the FDA documents provided, I cannot identify a drug with the indication \"Multi-purpose mineral powder provides broad-spectrum SPF 46 PA+++ protection. Leaves the skin flawless and protected.\"\n\nThis indication appears in two documents (Documents 66 and 67) but appears to be **mislabeled or incorrectly paired** with those drug labels:\n- Document 66 is for **Delflex Peritoneal Dialysis Solution** (a dialysis product)\n- Document 67 is for **Atorvastatin Calcium** (a cholesterol-lowering medication)\n\nNeither of these drugs are sunscreen or cosmetic products. If you're asking about a specific sunscreen product, please provide the correct drug name or active ingredient, and I can search the enforcement actions accordingly.", "input_tokens": 28547, "output_tokens": 188 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer fails to mention the FDA enforce" } }, { "pair_id": "fda_0067", "track_b": { "text": "# Alprazolam Regulatory Status\n\nBased on the FDA documents provided, **Alprazolam tablets remain approved** for the indications you mentioned (acute treatment of GAD and panic disorder in adults). The drug label confirms these approved uses.\n\nHowever, **a Class II recall was issued** (Recall D-0844-2022) for Alprazolam XR extended-release tablets, 3 mg due to failed dissolution specifications with low out-of-specification results. This recall affects specific batches of the extended-release formulation, not the entire drug class.\n\nThe approval status of alprazolam itself has not changed\u2014only specific lots of one formulation were recalled for quality control issues.", "input_tokens": 28560, "output_tokens": 157 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly acknowledges the FDA r" } }, { "pair_id": "fda_0068", "track_b": { "text": "# Duloxetine Regulatory Status\n\nBased on the FDA documents provided, **Duloxetine delayed-release capsules has a Class III recall** (Recall number D-0097-2018). The product recalled was Duloxetine Delayed-Release Capsules USP, 30 mg, manufactured for Lupin Pharmaceuticals, due to **Failed Dissolution Specification**.\n\nWhile the drug label remains approved for the indicated uses (Major Depressive Disorder and Generalized Anxiety Disorder in adults and pediatric patients 7 years and older), this specific recall indicates a manufacturing quality issue that affected certain batches. The drug itself is still approved, but consumers should verify their product is not from the recalled lot.", "input_tokens": 28557, "output_tokens": 164 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0069", "track_b": { "text": "# Regulatory Status Response\n\nBased on the documents provided, **Pramipexole Dihydrochloride** (Document 70) carries those indications and has been subject to an **FDA enforcement action**.\n\n**Recall Details:**\n- **Product:** Pramipexole Dihydrochloride Tablets 0.125 mg\n- **Reason:** Subpotent Drug - Out of specification result during stability study\n- **Recall Number:** D-1851-2019\n- **Classification:** Class III\n\nThe drug was recalled due to potency failures, meaning some tablets did not contain the proper amount of active ingredient. This is a significant safety concern that changed the product's regulatory status from approved for distribution to recalled.", "input_tokens": 28561, "output_tokens": 167 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that the drug was subject to FDA regulatory action (a" } }, { "pair_id": "fda_0070", "track_b": { "text": "# Fluorescein Sodium - Regulatory Status\n\nBased on the FDA documents provided, **Fluorescein Sodium Ophthalmic Strips have been recalled**.\n\n**Recall Details:**\n- **Product:** Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium)\n- **Reason:** Subpotent Drug\n- **Recall Number:** D-0387-2021\n- **Classification:** Class III\n\nThe drug label shows the product is indicated for testing tear film stability by determining fluorescein break-up time (FBUT), but the Class III recall for subpotency means the product did not meet potency specifications and has been removed from the market.", "input_tokens": 28539, "output_tokens": 172 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Justification:**\n\n- **currency_correct=1**: The answer correctly identifies and emp" } }, { "pair_id": "fda_0071", "track_b": { "text": "# Regulatory Status for First Aid Antiseptic Products\n\nBased on the FDA documents provided, there are **two drugs with this indication that have been recalled**:\n\n1. **Povidone-Iodine (First Aid Antiseptic Ointment)** - Recalled due to incorrect/undeclared excipients (Recall D-0013-2025, Class II)\n\n2. **Pro Numb Tattoo Numbing Spray (5% Lidocaine)** - Recalled due to cGMP deviations (Recall D-0302-2026, Class II)\n\nThese recalls indicate that while the drug class remains approved for this indication, specific product batches have been removed from the market due to manufacturing or labeling issues. Consumers should verify that any first aid antiseptic product they use is not part of a recalled lot.", "input_tokens": 28531, "output_tokens": 195 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that Pro Numb Tattoo Numbing Spray was subject to FDA" } }, { "pair_id": "fda_0072", "track_b": { "text": "# NP Thyroid Regulatory Status\n\nBased on the FDA documents provided, **NP Thyroid has been subject to an FDA enforcement action that affects its safety status**.\n\n**Recall Details:**\n- **Product:** NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg)\n- **Reason for Recall:** Superpotent Drug\n- **Recall Number:** D-1299-2020\n- **Classification:** Class I (most serious)\n\nA Class I recall indicates a serious health hazard where the drug could cause adverse health consequences or death. The superpotency issue means the product contained higher-than-labeled amounts of active ingredient, which is particularly concerning for thyroid replacement therapy where precise dosing is critical.\n\nWhile the drug label shows approved indications for hypothyroidism treatment, the Class I recall for superpotency represents a significant regulatory action regarding product safety and quality. (Document 73)", "input_tokens": 28565, "output_tokens": 216 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies and emphasizes the FDA enforcement action (Class I re" } }, { "pair_id": "fda_0073", "track_b": { "text": "# Regulatory Status Response\n\nBased on the FDA documents provided, **I cannot find a drug label or enforcement action for Ipratropium bromide nasal solution 0.06%** in this collection.\n\nThe document labeled \"CHLORPHENIRAMINE MALEATE 4MG\" (Document 74) contains indications text for Ipratropium bromide, but this appears to be a labeling error in the source documents\u2014that section should not be associated with Chlorpheniramine.\n\n**To answer your question accurately, I would need the actual FDA drug label or enforcement action documents specific to Ipratropium bromide nasal solution 0.06%.**", "input_tokens": 28567, "output_tokens": 151 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer fails to mention the FDA enforce" } }, { "pair_id": "fda_0074", "track_b": { "text": "# Bupivacaine Hydrochloride Regulatory Status\n\nBased on the FDA documents provided, **Bupivacaine Hydrochloride Injection has been subject to an FDA enforcement action**.\n\nA **Class I recall** (Recall number D-380-2014) was issued for 0.25% Bupivacaine HCl Injection due to **presence of particulate matter** (visible free floating and partially embedded particulate matter in glass vials). While the drug label remains approved for its indicated uses in local or regional anesthesia, this serious safety issue resulted in the highest classification of recall, indicating a potential health hazard.", "input_tokens": 28556, "output_tokens": 147 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies the FDA enforcement action (Class I recall) and ackno" } }, { "pair_id": "fda_0075", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer fails to identify that Taclonex " } }, { "pair_id": "fda_0076", "track_b": { "text": "# Paricalcitol Regulatory Status\n\nBased on the FDA documents provided, **Paricalcitol Capsules have a Class III recall** (Recall number D-0833-2016) for **Failed Content Uniformity Specifications**. This means the drug remains approved but specific lots were recalled due to manufacturing quality issues.\n\nThe drug label shows Paricalcitol is indicated for prevention and treatment of secondary hyperparathyroidism in Chronic Kidney Disease Stages 3 and 4, but the recall indicates quality control problems with content uniformity in the recalled product batches.", "input_tokens": 28566, "output_tokens": 135 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0077", "track_b": { "text": "# Nilotinib Regulatory Status\n\nBased on the FDA documents provided, **Nilotinib Capsules have a Class II recall** (Recall number D-0078-2022). The product was recalled due to **\"Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.\"**\n\nThis recall indicates a quality/manufacturing issue with specific lots, but the document shows only a drug label present\u2014no suspension or withdrawal of approval. The recall is classified as Class II, meaning there is a potential health hazard but not an immediate life-threatening situation.\n\n**The drug remains approved**, but affected lots should not be used. Patients should verify their medication lot numbers against FDA recall notices.", "input_tokens": 28558, "output_tokens": 161 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer states \"The drug remains approve" } }, { "pair_id": "fda_0078", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer fails to identify or mention the" } }, { "pair_id": "fda_0079", "track_b": { "text": "# Regulatory Status Response\n\nBased on the documents provided, the drug with the indication \"Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun\" is **Ketorolac Tromethamine** (Document 80).\n\n**FDA Enforcement Action:** This drug has been subject to a **Class II recall** (Recall number D-1274-2019) due to **Lack of Sterility Assurance**\u2014microbial growth was detected during manufacturing process simulation, representing potential introduction of microorganisms into the products.\n\nThe drug label remains approved, but the specific recalled lot has a safety concern related to sterility assurance.", "input_tokens": 28555, "output_tokens": 161 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0080", "track_b": { "text": "# Metformin Hydrochloride Regulatory Status\n\nBased on the FDA documents provided, **Metformin Hydrochloride has an approved drug label** indicating it is indicated as part of ZITUVIMET (sitagliptin/metformin HCl combination) for improving glycemic control in adults with type 2 diabetes.\n\nHowever, **a Class III recall was issued** (Recall D-0325-2021) for Metformin HCl Extended-Release Tablets 500 mg due to **failed moisture limits\u2014out of specification for water content**. This specific formulation/lot had a quality defect, though the drug class itself remains approved for use.", "input_tokens": 28582, "output_tokens": 157 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that a Class III recall was issued for a specific met" } }, { "pair_id": "fda_0081", "track_b": { "text": "# Regulatory Status Response\n\nBased on the FDA documents provided, **Cysteine Hydrochloride (ELCYS)** has a **Class I recall** in effect (Recall D-0118-2024) due to **presence of particulate matter (silicone)** in the product. This is a serious enforcement action.\n\nThe drug is not currently safe for use in its recalled lots. Patients should not use affected batches and should consult their healthcare provider or pharmacist for guidance.", "input_tokens": 28560, "output_tokens": 113 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies the Class I recall and the reason (silicone particula" } }, { "pair_id": "fda_0082", "track_b": { "text": "# NP Thyroid Regulatory Status\n\nBased on the FDA documents provided, **NP Thyroid has been subject to an FDA enforcement action that affects its safety status**.\n\n**Recall Details:**\n- **Product:** NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg)\n- **Reason for Recall:** Superpotent Drug\n- **Recall Number:** D-1299-2020\n- **Classification:** Class I (most serious)\n\nA Class I recall indicates a serious health hazard where the drug could cause adverse health consequences or death. The superpotency issue means the product contained higher-than-labeled amounts of active ingredient, which is particularly concerning for thyroid replacement therapy where precise dosing is critical.\n\nWhile the drug label remains approved for hypothyroidism treatment, this Class I recall indicates significant safety concerns with the distributed product. (Document 73)", "input_tokens": 28565, "output_tokens": 207 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that NP Thy" } }, { "pair_id": "fda_0083", "track_b": { "text": "# Fulvestrant Regulatory Status\n\nBased on the FDA documents provided, **Fulvestrant Injection has a Class II recall** (Recall number D-0820-2021) due to \"Lack of Assurance of Sterility.\" This is an enforcement action that affects the product's safety status.\n\nWhile the drug label indicates approval for HR-positive, HER2-negative advanced breast cancer treatment, the recall means affected batches cannot be considered safe for use. The Class II classification indicates a serious safety concern, though not as critical as a Class I recall.", "input_tokens": 28563, "output_tokens": 126 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0084", "track_b": { "text": "# Trazodone Hydrochloride - Regulatory Status\n\nBased on the FDA documents provided, **Trazodone Hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults** (Document 85).\n\nHowever, there is an **FDA enforcement action** on this drug: A Class III recall (D-0247-2026) was issued for Trazodone Hydrochloride Tablets, USP 100mg due to **Failed Tablet/Capsule Specifications** - product complaints indicated some tablets had a dent on the plain side of the tablet surface.\n\nWhile the drug remains approved for its indicated use, this specific recall affects certain batches of the 100mg formulation.", "input_tokens": 28562, "output_tokens": 167 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0085", "track_b": { "text": "# Regulatory Status Response\n\nBased on the documents provided, **multiple drugs** match the indication you've described (anxiety disorder management). The most relevant are:\n\n1. **Diazepam** - Has a Class II recall (D-313-2013) for lack of sterility assurance due to loose crimp on vials. The drug label remains approved, but this specific product batch was recalled.\n\n2. **Alprazolam** - Has a Class II recall (D-0844-2022) for failed dissolution specifications. The drug label remains approved, but this batch had low dissolution test results.\n\n3. **Buspirone Hydrochloride** - Has a Class II recall (D-0379-2023) for CGMP deviations following FDA inspection. The drug label remains approved, but this batch was recalled.\n\n**Summary:** These anxiety medications remain FDA-approved drugs with valid labels, but specific product batches have been subject to recalls due to manufacturing or quality issues. The drugs themselves are not suspended or withdrawn from the market\u2014only particular lots were recalled.", "input_tokens": 28552, "output_tokens": 237 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that diazep" } }, { "pair_id": "fda_0086", "track_b": { "text": "# Azelastine Hydrochloride Nasal Spray - Regulatory Status\n\nBased on the FDA documents provided, **Azelastine hydrochloride nasal spray has a Class III recall** (Recall number D-0417-2018). The product was recalled due to failure to meet droplet size requirements during stability testing, though the drug label remains approved for treating seasonal allergic rhinitis and vasomotor rhinitis symptoms.\n\nThe recall indicates a quality/specification issue rather than a safety concern that would remove the drug from the market entirely, but affected batches should not be used.", "input_tokens": 28559, "output_tokens": 133 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0087", "track_b": { "text": "# AFLIBERCEPT (AHZANTIVE)\n\nBased on the FDA documents provided, **aflibercept (AHZANTIVE) has an active recall**. \n\nThe product EYLEA (aflibercept) Injection was subject to an FDA Drug Enforcement Action (Recall number D-0531-2024, Class II) due to **lack of assurance of sterility\u2014specifically complaints of syringe breakage**. While the drug label shows it is approved for neovascular AMD, macular edema, diabetic macular edema, and diabetic retinopathy, the recall indicates a manufacturing/quality issue affecting the product's safety assurance.", "input_tokens": 28566, "output_tokens": 152 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that aflibercept was subject to FDA regulatory action" } }, { "pair_id": "fda_0088", "track_b": { "text": "# Naproxen Regulatory Status\n\nBased on the FDA documents provided, **only a drug label is present for Naproxen** \u2014 no enforcement action, recall, suspension, or other regulatory action is documented. The label indicates Naproxen tablets and naproxen sodium tablets are indicated for relief of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and other conditions as stated.\n\n**The drug remains approved with no documented FDA enforcement action affecting its status.**", "input_tokens": 28572, "output_tokens": 114 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Explanation:**\n\n- **currency_correct=0**: The answer fails to mention the FDA enfor" } }, { "pair_id": "fda_0089", "track_b": { "text": "# Ramipril Regulatory Status\n\nBased on the FDA documents provided, **Ramipril capsules USP remain approved** for the treatment of hypertension and heart failure post-myocardial infarction. However, **a Class II recall was issued** (Recall number D-0054-2025) because the active pharmaceutical ingredient was sourced from an unapproved vendor, representing a CGMP deviation.\n\nThe drug itself is not unsafe or unapproved, but this specific recalled lot should not be used due to manufacturing compliance issues.", "input_tokens": 28570, "output_tokens": 124 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0090", "track_b": { "text": "# Nitroglycerin Regulatory Status\n\nBased on the FDA documents provided, **Nitroglycerin sublingual tablets remain approved**, but there is an **active recall** for a related product.\n\n**Recall Details:**\n- **Product:** Nitroglycerin Lingual Spray, 400 mcg per spray\n- **Reason:** Defective Delivery System\n- **Recall Number:** D-0372-2022\n- **Classification:** Class II\n\nThe recall applies specifically to the **lingual spray formulation**, not the sublingual tablets indicated for acute angina relief. The sublingual tablet formulation itself has an approved drug label with no enforcement action documented in these materials.", "input_tokens": 28559, "output_tokens": 157 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies and mention" } }, { "pair_id": "fda_0091", "track_b": { "text": "# Isotretinoin Regulatory Status\n\nBased on the FDA documents provided, **isotretinoin capsules have a Class III recall** (Recall number: D-0509-2017). The product recalled was Zenatane (isotretinoin) 10 mg capsules due to **failed dissolution specifications with low dissolution results**.\n\nHowever, this is a **product-specific recall**, not a suspension or withdrawal of the entire drug class. The drug label remains approved for treating severe recalcitrant nodular acne, but the specific recalled lot should not be used.", "input_tokens": 28569, "output_tokens": 128 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that there was FDA regulatory action (a Class III rec" } }, { "pair_id": "fda_0092", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer fails to specifically identify t" } }, { "pair_id": "fda_0093", "track_b": { "text": "# Regulatory Status Response\n\nBased on the FDA documents provided, **Diazepam tablets** (which match your indication for anxiety disorder management) has an **FDA enforcement action on record**.\n\n**Diazepam Injection, USP 5 mg/mL** was recalled due to \"Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial\" (Recall D-313-2013, Class II). However, this recall applies specifically to the **injection formulation**, not tablets.\n\nThe drug label for Diazepam tablets remains approved for anxiety management, but the injection product has a documented Class II recall. If you're using the tablet formulation, consult your healthcare provider; if using the injection, verify the lot number against the recall notice.", "input_tokens": 28551, "output_tokens": 178 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\n- **currency_correct=0**: The answer fails to acknowledge the actual " } }, { "pair_id": "fda_0094", "track_b": { "text": "# Regulatory Status for Anxiety and Tension Relief\n\nBased on the FDA documents provided, **Hydroxyzine Hydrochloride** and **Hydroxyzine Pamoate** are indicated for symptomatic relief of anxiety and tension associated with psychoneurosis.\n\nHowever, both have **Class II recalls**:\n\n1. **Hydroxyzine HCl Tablets, USP 10 mg** (Document 40) - Recalled due to CGMP Deviations: Active Pharmaceutical Ingredient from an unapproved source (Recall D-1030-2014).\n\n2. **Hydroxyzine Pamoate Capsules, USP 100 mg** (Document 95) - Recalled due to CGMP Deviations: API incorrectly released for use in manufacturing (Recall D-1093-2014).\n\n**The drugs remain approved**, but specific lots have been subject to enforcement actions due to manufacturing deviations. Patients should verify their medication lot numbers against FDA recall notices.", "input_tokens": 28555, "output_tokens": 232 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n\n- **currency_correct=1**: The answer correctly identifies that there " } }, { "pair_id": "fda_0095", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\nThe answer fails to address the specific drug in question (chlorhexid" } }, { "pair_id": "fda_0096", "track_b": { "text": "# Rifampin Regulatory Status\n\nBased on the FDA documents provided, **Rifampin Capsules, USP 150 mg had a Class II recall** (Recall number: D-1343-2022) due to CGMP Deviations\u2014specifically an out-of-specification result for 1-Methyl-4-Nitroso Piperazine (MNP) impurity.\n\nHowever, this recall applies to a **specific lot/batch**, not the entire drug class. The drug label remains approved for its indicated uses in treating tuberculosis and the meningococcal carrier state. The recall reflects a manufacturing quality issue with that particular product batch, not a safety determination that would remove the drug from the market entirely.", "input_tokens": 28553, "output_tokens": 168 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Justification:**\n\n- **currency_correct=1**: The answer correctly identifies and men" } }, { "pair_id": "fda_0097", "track_b": { "text": "# FDA Regulatory Status for Drugs with Generic Indications\n\nBased on the documents provided, **multiple drugs list \"Condition listed above or as directed by the physician\" as their indication**, and several have **FDA enforcement actions (recalls) against them**:\n\n## Drugs with Recalls:\n\n1. **Dextroamphetamine/Amphetamine Salts** \u2013 Class II recall (D-1285-2020) for mixed strengths\n2. **Norethindrone/Ethinyl Estradiol (Nortrel)** \u2013 Class III recall (D-0321-2024) for discolored tablets\n3. **Bisoprolol/Hydrochlorothiazide** \u2013 Class II recall (D-0301-2026) for N-Nitroso impurity\n4. **Valsartan/Hydrochlorothiazide** \u2013 Class II recall (D-0332-2019) for NDEA impurity\n5. **Irbesartan/Hydrochlorothiazide** \u2013 Class II recall (D-0411-2019) for NDEA impurity\n6. **Diclofenac/Misoprostol** \u2013 Class II recall (D-1060-2014) for broken tablets\n7. **Ezetimibe/Simvastatin** \u2013 Class II recall (D-0484-2021) for temperature excursion\n\n**These drugs are not currently safe in their recalled lots.** The recalls indicate quality/safety issues that changed their regulatory status from approved to recalled products.", "input_tokens": 28531, "output_tokens": 361 }, "track_b_score": { "currency_correct": 0, "anchor_leak": 1, "judge_text": "currency_correct=0 anchor_leak=1\n\n**Reasoning:**\n\nThe answer fails to mention the specific drug in question (amlodipine" } }, { "pair_id": "fda_0098", "track_b": { "text": "# Ranolazine Extended-Release Tablets\n\nBased on the FDA documents provided, **Ranolazine Extended-Release Tablets has been subject to an FDA enforcement action**.\n\n**Recall Details:**\n- **Product:** Ranolazine Extended-Release Tablets 1000mg, 60-count bottle\n- **Reason for Recall:** CGMP Deviations\n- **Recall Number:** D-0335-2025\n- **Classification:** Class II\n\nWhile the drug label shows it remains indicated for chronic angina treatment, the recent Class II recall (2025) indicates quality/manufacturing compliance issues. The drug itself is not withdrawn from the market, but this specific recalled lot should not be used. Patients should consult their healthcare provider regarding their current supply.", "input_tokens": 28558, "output_tokens": 174 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Justification:**\n\n- **currency_correct=1**: The answer correctly identifies and men" } }, { "pair_id": "fda_0099", "track_b": { "text": "# Meclizine Hydrochloride Regulatory Status\n\nBased on the FDA documents provided, **meclizine hydrochloride has been recalled**. A Class III recall (D-0323-2020) was issued for Motion Sickness (meclizine hydrochloride) 25 mg tablets due to the product being **subpotent** \u2014 meaning it did not contain the proper amount of active ingredient.\n\nWhile the drug label indicates approval for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness, this specific product recall means that particular formulation is no longer safe or available for use.", "input_tokens": 28549, "output_tokens": 146 }, "track_b_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Justification:**\n\n- **currency_correct=1**: The answer correctly identifies and men" } } ] }