{ "as_of": "2026-05-09T14:52:36.665844", "track_a_model": "claude-haiku-4-5", "n": 100, "track_a": { "currency_correct": 0.99, "anchor_leak": 0.01, "p50_ms": 4555.970191955566, "p95_ms": 12495.399236679077, "input_tokens": 270400, "output_tokens": 12873, "cost_usd": 0.334765 }, "track_b": { "_skipped": true, "reason": "track_a_only flag set" }, "rows": [ { "pair_id": "fda_0000", "drug": "dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 72285.19988059998, "track_a": { "text": "Yes, there has been regulatory action. Multiple recalls have been issued for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate products:\n\n- **Doc 5** (ACTIVE, effective 2020-05-22): Teva's 5 mg tablets recalled for mixed strengths (Recall D-1285-2020, Class II)\n- **Doc 3** (ACTIVE, effective 2025-08-28): Granules Pharmaceuticals' 20 mg extended-release capsules recalled for failed impurities/degradation specifications (Recall D-0672-2025, Class III)\n\nThese are current regulatory actions, indicating the drug has safety/quality issues requiring FDA enforcement.", "input_tokens": 2274, "output_tokens": 185 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 multiple FDA" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0001", "drug": "oxymetazoline", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4497.964859008789, "track_a": { "text": "Yes, there has been regulatory action on oxymetazoline. **Doc 7 and Doc 8** (both currently ACTIVE as of 2021-10-26) document an FDA Class II recall of No Drip Nasal Spray containing Oxymetazoline HCl 0.05% due to CGMP deviations from contaminated excipient (Recall number D-0623-2022). This indicates the product was subject to enforcement action, though the documents do not specify whether oxymetazoline itself remains approved for other formulations.", "input_tokens": 2479, "output_tokens": 129 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0002", "drug": "nelfinavir", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3932.5690269470215, "track_a": { "text": "Yes, there has been regulatory action on nelfinavir. **Doc 1** shows a Class II recall (effective 2014-01-01) for VIRACEPT\u00ae (nelfinavir mesylate) 625 mg tablets due to incorrect expiry date labeling. While **Docs 3 and 4** are marked ACTIVE and contain the same recall information, the presence of the recalled document indicates regulatory enforcement action has been taken on this product.", "input_tokens": 2786, "output_tokens": 104 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0003", "drug": "azilsartan kamedoxomil", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 7943.569898605347, "track_a": { "text": "Yes, there has been regulatory action on azilsartan medoxomil products. **Edarbi (azilsartan medoxomil) tablets 80 mg** has an active Class II recall (Docs 3 & 4, Recall D-0429-2021) due to CGMP deviations from temperature excursions during storage. Additionally, **Edarbyclor (azilsartan medoxomil/chlorthalidone)** also has an active Class II recall (Doc 5, Recall D-0430-2021) for the same reason. These products remain under FDA enforcement action.", "input_tokens": 2660, "output_tokens": 147 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0004", "drug": "enoxaparin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4607.428073883057, "track_a": { "text": "Yes, there has been regulatory action on enoxaparin. **Doc 1** shows a RECALLED enoxaparin sodium injection product (Sandoz Inc., NDC 0781-3299-69) due to CGMP deviations from temperature exposure (Recall D-0179-2024, Class II). While Docs 2 and 3 list the same product as \"ACTIVE,\" the recalled status in Doc 1 takes precedence, indicating this specific batch/formulation experienced a regulatory recall.", "input_tokens": 2558, "output_tokens": 117 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies that there W" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0005", "drug": "nizatidine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5199.159622192383, "track_a": { "text": "Yes, there has been regulatory action on nizatidine. **Doc 1** shows a RECALLED (regulatory action taken) FDA Drug Enforcement Action for Nizatidine Oral Solution 15 mg/mL distributed by Gemini Laboratories due to CGMP deviations and potential N-Nitrosodimethylamine (NDMA) contamination above FDA-established levels (Recall D-1253-2020, Class II). This indicates the product was subject to an FDA enforcement action.", "input_tokens": 2717, "output_tokens": 116 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that nizatidine was subject to FDA regulatory action " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0006", "drug": "norethindrone and ethinyl estradiol", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4523.519039154053, "track_a": { "text": "Yes, there has been regulatory action. **Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35** has an active FDA recall (Recall number D-0321-2024, Class III) due to discoloration of tablets, as documented in Doc 8 and Doc 9 (effective 2024-01-25). While the drug itself remains approved, this specific product formulation and batch are subject to an ongoing enforcement action.", "input_tokens": 2300, "output_tokens": 111 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0007", "drug": "haloperidol decanoate", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4404.523134231567, "track_a": { "text": "Yes, there has been regulatory action on haloperidol decanoate. Multiple active FDA Drug Enforcement Actions document Class II recalls for Haloperidol Decanoate Injection 50mg/mL due to lack of assurance of sterility and bacterial contamination in media fill testing (Docs 3, 5, 6 with recall number D-0356-2025, effective 2025-03-21). While the drug itself remains an approved product (Doc 2), the specific manufactured batches from Somerset Therapeutics Limited/BluePoint Laboratories have been recalled.", "input_tokens": 2152, "output_tokens": 131 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0008", "drug": "clindamycin phosphate/benzoyl peroxide/adapalene", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4195.9028244018555, "track_a": { "text": "Yes, there has been regulatory action. **CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) has been recalled** due to CGMP deviations\u2014the product was stored outside labeled storage temperature requirements (Doc 5 and Doc 6, both marked ACTIVE as of 2024-02-12). This is a current enforcement action, not a historical recall.", "input_tokens": 2408, "output_tokens": 94 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0009", "drug": "dapagliflozin and metformin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4605.2539348602295, "track_a": { "text": "Yes, there has been regulatory action on dapagliflozin and metformin products. **Xigduo XR (dapagliflozin/metformin HCl extended-release) 10 mg/1000 mg was recalled** due to CGMP deviations involving temperature excursion during storage (Recall D-0435-2021, Class II) \u2014 this recall remains **currently ACTIVE** as of the most recent documentation (Doc 5, Doc 6). While the drug is FDA-approved, the specific recalled batches should not be used.", "input_tokens": 2258, "output_tokens": 134 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0010", "drug": "guselkumab", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4457.664966583252, "track_a": { "text": "Yes, there has been regulatory action on guselkumab (Tremfya). The drug has an active Class III recall due to temperature abuse (Recall number D-0314-2021, effective 2021-03-09, per Doc 5 and Doc 6). While the product may remain approved for marketing, the specific batches affected by temperature abuse have been subject to FDA enforcement action.", "input_tokens": 3120, "output_tokens": 90 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies the FDA regulatory action (Class III recall for tempe" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0011", "drug": "morphine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4664.267063140869, "track_a": { "text": "Yes, there has been regulatory action on Morphine Sulfate Extended-Release Tablets, 60 mg. Documents 6 and 7 show **active FDA Drug Enforcement Actions** (effective 2019-04-10) for this product manufactured by Novel Laboratories/Lupin Pharmaceuticals (NDC 43386-542-01), with a Class III recall due to failed impurities/degradation specifications (Recall D-1245-2019). This indicates the product is subject to an ongoing regulatory enforcement action, not simply approved for unrestricted use.", "input_tokens": 2913, "output_tokens": 129 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies and mentions the FDA recall (Class III, D-1245-2019) " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0012", "drug": "buprenorphine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 10232.276916503906, "track_a": { "text": "Yes, there has been regulatory action on buprenorphine products. Multiple ACTIVE recalls are documented:\n\n1. **Belbuca (buprenorphine hydrochloride) buccal film 300 mcg** \u2013 ACTIVE recall (Doc 7, 9) for CGMP deviations due to temperature excursion during storage (Recall D-0448-2021, Class II).\n\n2. **Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg** \u2013 ACTIVE recall (Doc 8) for subpotent drug (out of specification for assay, Recall D-0649-2021, Class II).\n\nThese are Class II recalls, indicating serious safety concerns. While buprenorphine remains an FDA-approved drug, these specific products have been subject to enforcement actions.", "input_tokens": 2748, "output_tokens": 194 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 active recal" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0013", "drug": "cefdinir", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4657.328844070435, "track_a": { "text": "Yes, there has been regulatory action on cefdinir. **Doc 5 and Doc 6** (both currently ACTIVE) document an FDA Class II recall (D-0375-2019) of Cefdinir for Oral Suspension USP 125mg/5mL manufactured by Lupin Pharmaceuticals due to CGMP deviations\u2014specifically, product complaints indicating the reconstituted suspension was observed to be thick. This recall remains in effect.", "input_tokens": 2997, "output_tokens": 106 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0014", "drug": "ondansetron", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4555.970191955566, "track_a": { "text": "Yes, there has been regulatory action on ondansetron. Doc 1 shows a Class II recall (D-851-2013) for Ondansetron Injection, USP, 4mg/2mL due to presence of particulate matter. While Docs 6 and 7 also list this same recall as currently active, the existence of the recall indicates FDA regulatory action has been taken on this product.", "input_tokens": 3164, "output_tokens": 95 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0015", "drug": "bisoprolol fumarate and hydrochlorothiazide", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4708.042144775391, "track_a": { "text": "Yes, there has been regulatory action. Bisoprolol Fumarate and Hydrochlorothiazide tablets (2.5 mg/6.25 mg, NDC 29300-187-01, manufactured by UNICHEM LABORATORIES for UNICHEM PHARMACEUTICALS USA) are subject to an active FDA Drug Enforcement Action recall due to cGMP deviations\u2014specifically, failure to meet N-Nitroso Bisoprolol impurity specification limits (Recall D-0301-2026, Doc 7 and Doc 8). Additionally, a separate active recall exists for Bisoprolol Fumarate 5 mg tablets from the same manufacturer due to failed impurities/degradation specifications (Doc 9).", "input_tokens": 2363, "output_tokens": 170 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0016", "drug": "alteplase", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4865.424871444702, "track_a": { "text": "Yes, there has been regulatory action on alteplase. **Doc 1** shows a **Class II recall** (D-0509-2024) for Cathflo Activase (alteplase) 2mg vials due to lack of assurance of sterility from deformed stoppers. While **Docs 4 and 5** show this same recall as currently active, the existence of the recall indicates regulatory action has been taken against this product.", "input_tokens": 2877, "output_tokens": 103 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0017", "drug": "testosterone", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5884.568929672241, "track_a": { "text": "Yes, there has been regulatory action on testosterone products. **Doc 1** documents a Class III recall of Testosterone Topical Solution (30mg/1.5mL) manufactured by Lupin Pharmaceuticals, effective January 2019, due to defective pump mechanisms. Additionally, **Doc 5** shows an active Class I recall of Testosterone Cypionate Injection (2000 mg/10 mL) from Wilshire Pharmaceuticals, effective September 2019, due to labeling/carton mix-up. These recalls indicate significant regulatory enforcement actions against specific testosterone formulations.", "input_tokens": 3141, "output_tokens": 133 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions two FDA regul" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0018", "drug": "simvastatin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4607.310056686401, "track_a": { "text": "**Yes, there has been regulatory action on simvastatin.** Multiple recalls are documented: a Class III recall (Doc 2 & 4, Recall D-1842-2019) for Simvastatin Tablets USP 40 mg due to incorrect lot/expiration date labeling, and a Class II recall (Doc 1 & 5, Recall D-0484-2021) for Ezetimibe and Simvastatin Tablets 10-10mg due to CGMP temperature excursion deviations. Both recalls remain active in the current regulatory record.", "input_tokens": 1985, "output_tokens": 137 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0019", "drug": "diclofenac sodium and misoprostol", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5414.842128753662, "track_a": { "text": "Yes, there has been regulatory action on Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg. **Doc 6 and Doc 7** (both ACTIVE as of 2013-03-22) document an ongoing Class II recall for broken tablets manufactured by Watson Laboratories, Inc. (NDC 0591-0398-60). Additionally, **Doc 8** shows a separate ACTIVE Class III recall for Diclofenac Sodium Topical Gel due to failed pH specifications.", "input_tokens": 2899, "output_tokens": 129 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0020", "drug": "cetirizine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4527.468204498291, "track_a": { "text": "Yes, there has been regulatory action. Cetirizine Hydrochloride Tablets, USP 10mg (NDC# 72657-129-35, manufactured for Glenmark Therapeutics Inc. and distributed by Amazon) is subject to an active FDA Drug Enforcement Action recall (Recall number D-0348-2025, Classification: Class II) due to CGMP Deviations, as documented in Doc 8 and Doc 9 (effective 2025-03-13).", "input_tokens": 2470, "output_tokens": 117 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0021", "drug": "timolol", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5471.380949020386, "track_a": { "text": "Yes, there has been regulatory action on timolol products. **Betimol (timolol ophthalmic solution) 0.5%** has an active Class II recall (Recall D-0374-2024, Docs 4\u20135) due to lack of assurance of sterility, out-of-specification volume, and compromised container closure. Additionally, **Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%** (Apotex) has an active Class II recall (Recall D-0407-2026, Docs 6\u20137) for lack of assurance of sterility, and **Combigan (brimonidine tartrate/timolol maleate)** has an active Class III recall (Recall D-0077-2018, Doc 8) for failed impurities/degradation specifications.", "input_tokens": 2823, "output_tokens": 212 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0022", "drug": "estradiol", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 8235.228300094604, "track_a": { "text": "Yes, there has been regulatory action on estradiol products. **Minivelle (estradiol transdermal system)** has an active Class II recall (Doc 4 & 5, effective 2018-09-07) due to defective delivery system with out-of-specification adhesive properties (Recall number D-1209-2018).\n\nAdditionally, multiple estradiol-containing combination products have active recalls: **Norgestimate and Ethinyl Estradiol** (Doc 6, 2025), **Norethindrone Acetate and Ethinyl Estradiol** (Doc 7 & 9, 2017), and **Velivet (desogestrel and ethinyl estradiol)** (Doc 11, 2014) all have active enforcement actions for various quality defects.", "input_tokens": 2375, "output_tokens": 193 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 explicitly mentions multiple" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0023", "drug": "acetaminophen", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 6451.838970184326, "track_a": { "text": "**Acetaminophen has had regulatory action taken against specific products, but the drug itself remains FDA-approved.**\n\nMultiple acetaminophen-containing products have been subject to Class II recalls:\n- **Doc 1 (Recalled)**: Acetaminophen Child Bubble Gum Flavored Oral Suspension due to contaminated excipient\n- **Doc 5 (Active)**: Acetaminophen and Ibuprofen combination tablets due to CGMP deviations\n- **Doc 6 (Active)**: Acetaminophen with Codeine tablets due to labeling issues\n- **Doc 7 (Active)**: Hydrocodone Bitartrate and Acetaminophen tablets due to product mix-up\n- **Doc 8 (Active)**: Oxycodone and Acetaminophen tablets due to missing imprint\n\nThese are manufacturing/labeling enforcement actions against specific batches or formulations, not withdrawals of acetaminophen approval itself. The drug remains an approved OTC/Rx ingredient.", "input_tokens": 1485, "output_tokens": 239 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 acknowledges that reg" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0024", "drug": "gabapentin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4230.481863021851, "track_a": { "text": "Yes, there has been regulatory action on gabapentin. **Doc 1** shows a RECALLED (regulatory action taken) FDA Drug Enforcement Action for Gabapentin Capsules, USP, 300 mg, NDC 45963-556-11, manufactured by Actavis Pharma Manufacturing Pvt. Ltd., due to failed capsule specifications (clumping and breaking). Although **Docs 4 and 5** show active documents with the same product details, the recalled status in Doc 1 takes precedence, indicating this specific gabapentin product has been subject to FDA enforcement action.", "input_tokens": 2656, "output_tokens": 137 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that gabapentin was subject to FDA regulatory action " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0025", "drug": "azacitidine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4265.817880630493, "track_a": { "text": "Yes, there has been regulatory action on azacitidine. **Azacitidine for Injection 100mg/vial** (manufactured by Sindan Pharma SRL for BluePoint Laboratories, NDC 68001-313-56) was recalled due to subpotency\u2014out-of-specification assay results from a stability study (Recall D-1334-2022, Class III). This recall remains active as of the most recent documentation (Docs 4\u20135).", "input_tokens": 3282, "output_tokens": 115 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0026", "drug": "fluoxetine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5618.4351444244385, "track_a": { "text": "Yes, there has been regulatory action on fluoxetine. **Doc 1** shows a RECALLED fluoxetine product (Fluoxetine Capsules USP, 20 mg, NDC 50111-648-02 and 50111-648-03, manufactured by Pliva Krakow/Teva) due to elevated residual solvent impurity in the API exceeding the Threshold of Toxicological Concern. While Docs 3 and 4 are marked ACTIVE with the same product details, the presence of the recalled document indicates regulatory enforcement action has been taken on this specific fluoxetine formulation.", "input_tokens": 2715, "output_tokens": 148 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0027", "drug": "dapsone", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4107.779979705811, "track_a": { "text": "Yes, there has been regulatory action on Dapsone Gel 7.5%. **Doc 4 and Doc 5** show active FDA Drug Enforcement Actions (Recall number D-0038-2025, Class II) for Dapsone Gel 7.5% manufactured by Zydus Lifesciences due to crystallization. The recall remains currently active as of October 29, 2024.", "input_tokens": 2454, "output_tokens": 96 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0028", "drug": "paroxetine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4708.595037460327, "track_a": { "text": "Yes, there has been regulatory action on paroxetine. **Doc 1 and Doc 3** both document FDA Drug Enforcement Actions for Paroxetine Hydrochloride Tablets USP 30 mg (manufactured by Apotex Inc.) due to failed impurities/degradation specifications\u2014specifically out-of-specification results for the Amadori Glucose adduct of Paroxetine. Doc 3 shows this recall remains **currently ACTIVE** as of 2023-11-01, indicating an ongoing regulatory action against this product.", "input_tokens": 3218, "output_tokens": 127 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions FDA Drug Enfo" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0029", "drug": "valsartan and hydrochlorothiazide", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4507.5976848602295, "track_a": { "text": "**Yes, there has been regulatory action.** Valsartan and Hydrochlorothiazide Tablets USP 320/25 mg (Mylan Pharmaceuticals) was recalled due to CGMP deviations\u2014FDA analysis confirmed the presence of N-nitrosodiethylamine (NDEA) impurity in the API (Docs 4 & 5, Recall D-0332-2019). Additionally, Amlodipine and Valsartan Tablets containing valsartan were also recalled for the same NDEA impurity issue (Doc 10, Recall D-0312-2019).", "input_tokens": 2839, "output_tokens": 149 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0030", "drug": "albuterol", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5233.616352081299, "track_a": { "text": "Yes, there has been regulatory action on albuterol products. **Doc 1** shows a recalled Ventolin HFA (albuterol sulfate) inhalation aerosol with a Class II recall (D-1666-2012) due to failure to deliver proper metered dose\u2014the albuterol content per dose was below specification. Additionally, **Doc 4** documents a Class II recall of Airsupra (albuterol and budesonide combination) in 2025 for a defective delivery system. While albuterol remains an FDA-approved drug, these specific products have been subject to enforcement actions.", "input_tokens": 3101, "output_tokens": 143 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 two regulato" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0031", "drug": "phenytoin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4224.668025970459, "track_a": { "text": "Yes, there has been regulatory action on phenytoin products. **Doc 1** shows a **RECALLED** Extended Phenytoin Sodium Capsules (100 mg) distributed by Amneal Pharmaceuticals, effective January 1, 2023, due to failed dissolution specifications (Class II recall, D-0876-2023). While Docs 2 and 3 show the same product with \"ACTIVE\" status as of May 2023, the initial recall in Doc 1 indicates regulatory enforcement action was taken against this phenytoin formulation.", "input_tokens": 2757, "output_tokens": 127 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the recall (C" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0032", "drug": "hetastarch", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4553.473949432373, "track_a": { "text": "Yes, there has been regulatory action on hetastarch. **Doc 1** shows a **Class II recall** of HEXTEND 6% Hetastarch in Lactated Electrolyte Injection (effective 2013-01-01) due to lack of assurance of sterility\u2014the solution had potential to leak from the bag seal. This recalled status takes precedence over any active label status.", "input_tokens": 3077, "output_tokens": 92 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the Class II " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0033", "drug": "rimegepant", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4461.097955703735, "track_a": { "text": "Yes, there has been regulatory action on rimegepant. **Doc 1** shows a Class II recall of NURTEC ODT (rimegepant) 75mg due to CGMP deviations involving temperature excursion during storage (Recall D-0451-2021). While **Docs 3 and 4** list this same product as \"currently ACTIVE,\" they refer to the same enforcement action, indicating the recall remains in effect.", "input_tokens": 2389, "output_tokens": 104 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0034", "drug": "velpatasvir and sofosbuvir", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3985.8241081237793, "track_a": { "text": "Yes, there has been regulatory action. Sofosbuvir and Velpatasvir (400 mg/100 mg tablets) is subject to an active FDA Class II recall (Recall number D-0313-2025, effective March 7, 2025) due to defective container sealing causing tablets to be loose in the carton (Docs 3 and 4). This indicates the product remains under regulatory enforcement action.", "input_tokens": 2534, "output_tokens": 100 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0035", "drug": "norepinephrine bitartrate", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4260.0390911102295, "track_a": { "text": "Yes, there has been regulatory action on norepinephrine bitartrate. **Doc 4 and Doc 5** (both currently ACTIVE) document an FDA Class II recall of Levophed (norepinephrine bitartrate injection, 4 mg/4 mL) by Hospira, Inc., effective May 18, 2017, due to a GMP deviation involving a foreign stopper observed during packaging (Recall number D-0898-2017). The product remains under this active enforcement action.", "input_tokens": 2870, "output_tokens": 119 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0036", "drug": "azelaic acid", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4697.858095169067, "track_a": { "text": "Yes, there has been regulatory action on Azelaic Acid Gel, 15%. The product manufactured by Glenmark Pharmaceuticals has been subject to a Class II recall (Recall number D-0662-2025) due to CGMP deviations\u2014specifically market complaints of gritty texture (grainy appearance). This recall remains currently active as of the most recent documentation (Doc 4 and Doc 5, effective 2025-09-17).", "input_tokens": 2917, "output_tokens": 106 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0037", "drug": "candesartan cilexetil", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4621.505975723267, "track_a": { "text": "Yes, there has been regulatory action on Candesartan Cilexetil Tablets, USP 16 mg. An FDA Class III recall (D-0798-2021) was issued due to failed impurities/degradation specifications\u2014the product was out of specification for related compound (Doc 1). While Doc 4 and Doc 5 show active enforcement documents with the same recall number, the recalled status takes precedence, indicating this product experienced a regulatory enforcement action.", "input_tokens": 3102, "output_tokens": 108 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies and mentions the FDA Class III recall (D-0798-2021) w" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0038", "drug": "ezetimibe and simvastatin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4298.815965652466, "track_a": { "text": "Yes, there has been regulatory action on ezetimibe and simvastatin. **Doc 1** shows a Class II recall (D-0484-2021) for EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG due to CGMP deviations involving temperature excursion during storage. While **Docs 4 and 5** mark this same recall as currently active, the product remains subject to the enforcement action and is not in normal approved status without restriction.", "input_tokens": 2153, "output_tokens": 113 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the Class II " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0039", "drug": "hydroxyzine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 6451.891899108887, "track_a": { "text": "Yes, there has been regulatory action on hydroxyzine products. Multiple ACTIVE recalls are documented: **Doc 6 and Doc 7** show an ACTIVE Class II recall of HydrOXYzine HCI Tablets USP 10 mg (KVK-TECH) due to CGMP deviations involving unapproved API sources (Recall D-1030-2014), and **Doc 8 and Doc 9** show an ACTIVE Class II recall of Teva Hydroxyzine Pamoate Capsules USP 100 mg due to CGMP deviations with incorrectly released API (Recall D-1093-2014). These recalls indicate regulatory enforcement action against specific hydroxyzine products, though the drug itself remains FDA-approved for use.", "input_tokens": 2635, "output_tokens": 181 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 active recal" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0040", "drug": "metoprolol succinate er tablets", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5118.872165679932, "track_a": { "text": "Yes, there has been regulatory action on metoprolol succinate extended-release tablets. **Doc 1** shows a RECALLED (regulatory action taken) FDA Drug Enforcement Action effective 2023-01-01 for Metoprolol Succinate Extended-Release Tablets 25 mg manufactured by Alkem Laboratories, distributed by Ascend Laboratories (NDC 67877-590-01), due to failed dissolution specification (Recall D-0169-2023, Class II). Additionally, **Doc 3** documents an earlier Class II recall of Dr. Reddy's Metoprolol Succinate Extended-Release Tablets 50 mg for the same reason.", "input_tokens": 2816, "output_tokens": 155 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the FDA regul" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0041", "drug": "posaconazole", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5622.221946716309, "track_a": { "text": "Yes, there has been regulatory action on posaconazole. **Doc 1** shows a **RECALLED** (regulatory action taken) FDA Drug Enforcement Action for Posaconazole Delayed-Release Tablets, 100 mg, due to failed impurities/degradation specifications (Class II recall, D-0268-2023). Although Docs 2 and 3 also reference the same product with \"ACTIVE\" status, the recalled document takes precedence\u2014indicating this specific product batch/formulation experienced a regulatory enforcement action.", "input_tokens": 2938, "output_tokens": 123 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and emphasiz" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0042", "drug": "brimonidine tartrate and timolol", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5034.221172332764, "track_a": { "text": "Yes, there has been regulatory action on brimonidine tartrate/timolol maleate products. Multiple ACTIVE recalls are currently in effect:\n\n1. **Brimonidine Tartrate/Timolol Maleate 0.2%/0.5% (Apotex)** \u2013 Class II recall for lack of assurance of sterility (Docs 3 & 4, effective 2026-03-05).\n\n2. **Combigan (brimonidine tartrate/timolol maleate 0.2%/0.5%, Allergan)** \u2013 Class III recall for failed impurities/degradation specifications (Doc 6, effective 2017-10-19).\n\nThese products remain under FDA enforcement action and should not be considered fully approved without restriction.", "input_tokens": 2644, "output_tokens": 185 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 multiple act" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0043", "drug": "rizatriptan", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4824.127912521362, "track_a": { "text": "Yes, there has been regulatory action on rizatriptan. **Doc 1** shows a RECALLED (regulatory action taken) FDA Drug Enforcement Action for Rizatriptan Benzoate Film Coated Tablets, 10 mg, due to out-of-specification test results in organic impurities testing. While Docs 3 and 4 also list this same product as currently ACTIVE enforcement actions, the presence of the recalled document indicates regulatory action has been taken against this specific product.", "input_tokens": 2507, "output_tokens": 112 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0044", "drug": "promethazine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 7013.765811920166, "track_a": { "text": "Yes, there has been regulatory action on promethazine. **Doc 5 and Doc 6** (both marked ACTIVE) document an FDA Class II recall of **Promethazine Hydrochloride Tablets, USP, 25 mg** (NDC 68382-041-01) manufactured by Cadila Healthcared Ltd. and distributed by Zydus Pharmaceuticals USA Inc., due to the presence of foreign atenolol tablets mixed into promethazine bottles (Recall D-1342-2014, effective May 8, 2014).", "input_tokens": 2694, "output_tokens": 134 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0045", "drug": "verapamil", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4260.812997817993, "track_a": { "text": "Yes, there has been regulatory action on verapamil. **Doc 1** shows a RECALLED verapamil hydrochloride injection (5 mg/2mL) due to cross-contamination with other products. Although **Docs 2 and 3** list the same product as currently ACTIVE, the presence of the recalled document (Doc 1) indicates that regulatory enforcement action has been taken against this specific verapamil product.", "input_tokens": 3150, "output_tokens": 101 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0046", "drug": "cefazolin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4517.729997634888, "track_a": { "text": "Yes, there has been regulatory action on cefazolin. **Doc 4 and Doc 5** show that Cefazolin for injection USP (2 g, 50 mL duplex container, B. Braun Medical Inc., NDC 0264-3105-11) has an active FDA Drug Enforcement Action (Recall number D-1118-2022, Class II) due to cGMP deviations from temperature abuse, effective as of April 13, 2022. Additionally, **Doc 8** documents a related Class I recall involving a label mix-up where some cefazolin vials were mislabeled as penicillin G potassium.", "input_tokens": 2900, "output_tokens": 158 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the FDA regul" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0047", "drug": "topical gel for muscle cramping and restlessness", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4561.56587600708, "track_a": { "text": "Yes, there has been regulatory action. **NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel** was recalled due to CGMP deviations involving water contamination in active ingredients supplied by the manufacturer King Bio Inc. (Doc 1 \u2014 RECALLED status; also documented in Docs 2 and 4 as ACTIVE enforcement actions). The product is not currently approved for safe use.", "input_tokens": 2502, "output_tokens": 101 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0048", "drug": "capecitabine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 14744.509935379028, "track_a": { "text": "Yes, there has been regulatory action on capecitabine. **Capecitabine tablets USP 500 mg (NDC 0093-7474-89) manufactured by Teva was recalled due to failed dissolution specifications** \u2014 the product showed low test results at the 18-month time-point (Recall number D-0732-2016, Class II). This recall remains active as documented in **Doc 4 and Doc 5** (effective 2015-12-21).", "input_tokens": 3314, "output_tokens": 114 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the regulator" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0049", "drug": "methylphenidate", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 12902.878999710083, "track_a": { "text": "Yes, there has been regulatory action on methylphenidate. **Doc 1** shows a recalled Daytrana (methylphenidate transdermal system) 20 mg patch due to defective delivery system with out-of-specification mechanical peel force results (Recall D-0429-2017). While **Docs 3 and 4** list the same product as \"currently ACTIVE,\" the RECALLED banner in Doc 1 takes precedence, indicating this specific formulation/lot experienced FDA enforcement action for manufacturing defects.", "input_tokens": 2212, "output_tokens": 121 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0050", "drug": "doxycycline hyclate", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 75935.62602996826, "track_a": { "text": "Yes, there has been regulatory action on doxycycline hyclate. Doc 3 and Doc 4 show an active FDA Drug Enforcement Action (recall D-1274-2020, Class II) for Doxycycline Hyclate Tablets USP 100 mg due to failed dissolution specifications at the 24-month time point. The recall remains currently active as of the document effective date of 2020-05-13.", "input_tokens": 2819, "output_tokens": 103 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0051", "drug": "povidone-iodine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4855.059862136841, "track_a": { "text": "Yes, there has been regulatory action against povidone-iodine products. **Doc 7 and Doc 9** (both ACTIVE as of 2024-09-11) document an FDA recall of \"First Aid Antiseptic Ointment, Povidone Iodine USP 10%\" distributed by Rugby Laboratories due to incorrect/undeclared excipients\u2014the product contained polyethylene glycol 40 instead of the labeled mineral oil and petrolatum. This indicates the product is not currently approved in its recalled form.", "input_tokens": 2468, "output_tokens": 125 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies that there W" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0052", "drug": "hydromorphone", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4303.443193435669, "track_a": { "text": "Yes, there has been regulatory action on hydromorphone. **Doc 4 and Doc 5** document an active FDA Drug Enforcement Action (effective 2014-10-01) for Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, with a recall due to \"Lack of Assurance of Sterility.\" These are marked as currently ACTIVE enforcement actions, indicating ongoing regulatory concern with this product.", "input_tokens": 2753, "output_tokens": 102 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0053", "drug": "levothyroxine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4398.170232772827, "track_a": { "text": "Yes, there has been regulatory action on levothyroxine. **Doc 2** shows an active FDA recall (effective 2024-11-25) for Levothyroxine Sodium Tablets USP 150 mcg manufactured by Mylan Pharmaceuticals due to potency failures (superpotent and subpotent drug issues, Recall D-0120-2025, Class II). While levothyroxine remains an FDA-approved drug class, this specific product batch has been subject to enforcement action.", "input_tokens": 2039, "output_tokens": 119 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0054", "drug": "clonidine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4817.207098007202, "track_a": { "text": "Yes, there has been regulatory action on clonidine. **Doc 4 and Doc 5** show an active FDA Drug Enforcement Action (Class II recall, D-1091-2022) for Duraclon (clonidine HCl injection, USP) due to cGMP deviations from temperature abuse, effective April 13, 2022. This indicates regulatory action has been taken on this clonidine product, though the recall status applies to specific lots/batches rather than the drug's overall approval.", "input_tokens": 3126, "output_tokens": 120 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0055", "drug": "liothyronine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4478.0309200286865, "track_a": { "text": "Yes, there has been regulatory action on liothyronine. **Doc 2** shows an active FDA Drug Enforcement Action (Class II recall, effective 2023-12-04) for Liothyronine Sodium Tablets USP 5 mcg distributed by Sun Pharmaceutical, with the reason being \"Failed Impurities/Degradation Specifications\" (Recall number D-0150-2024). This indicates the product was recalled due to quality failures, though the drug itself remains an approved medication\u2014this specific batch/product had regulatory issues.", "input_tokens": 2084, "output_tokens": 126 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0056", "drug": "moxifloxacin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5988.226890563965, "track_a": { "text": "Yes, there has been regulatory action on moxifloxacin. **Doc 7 and Doc 8** document an active FDA Drug Enforcement Action (Recall number D-1050-2018, Class III) for Moxifloxacin Ophthalmic Solution USP 0.5% manufactured by Lupin Pharmaceuticals, issued on 2018-07-26, due to failed impurities/degradation specifications. This indicates the product was recalled, though the generic drug itself may still be approvable under different manufacturing conditions.", "input_tokens": 3015, "output_tokens": 127 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the FDA Drug " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0057", "drug": "risedronate", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 8575.299739837646, "track_a": { "text": "Yes, there has been regulatory action on risedronate. **Doc 2 and Doc 3** show an active FDA Drug Enforcement Action (Class III recall, D-0762-2022) for Risedronate Sodium Tablets, 5 mg, due to failed content uniformity specifications. While an older recalled label exists (Doc 1, from 2010), the current active enforcement action takes precedence\u2014risedronate products have been subject to recall as of March 2022.", "input_tokens": 3105, "output_tokens": 113 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies that risedro" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0058", "drug": "clotrimazole", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 7385.72883605957, "track_a": { "text": "Yes, there has been regulatory action on clotrimazole. **Doc 1 and Doc 2** document an FDA Class II recall (D-0154-2021) of Kroger Athlete's Foot Cream, Clotrimazole Cream USP 1%, due to an unknown degradation impurity detected above specification limits. However, this recall applies to a specific product batch/manufacturer, not clotrimazole as a drug substance itself\u2014the active ingredient clotrimazole remains FDA-approved for topical antifungal use.", "input_tokens": 2974, "output_tokens": 126 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0059", "drug": "atomoxetine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 10077.197074890137, "track_a": { "text": "**Yes, there has been regulatory action on atomoxetine.** An active FDA Drug Enforcement Action (Recall number D-0236-2025, Class II) is currently in effect for Atomoxetine Capsules, USP 80 mg manufactured by Glenmark Pharmaceuticals due to the presence of N-Nitroso Atomoxetine Impurity above FDA-recommended limits (Docs 4 & 5). This indicates a current safety/quality issue requiring regulatory intervention, though the drug itself remains an approved medication with this specific batch/product under recall.", "input_tokens": 2675, "output_tokens": 132 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the FDA Drug " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0060", "drug": "irbesartan and hydrochlorothiazide", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 8984.848737716675, "track_a": { "text": "**Regulatory action has been taken on Irbesartan and Hydrochlorothiazide.** Documents 4 and 5 show ACTIVE FDA Drug Enforcement Actions (effective 2019-01-18) for Irbesartan and Hydrochlorothiazide Tablets 300/12.5 mg manufactured by Zhejiang Huahai Pharmaceutical, citing CGMP deviations due to N-nitrosodimethylamine (NDEA) impurity above acceptable limits. Additionally, Document 6 documents an ACTIVE recall for Irbesartan 300 mg tablets from the same manufacturer for the same impurity issue.", "input_tokens": 2316, "output_tokens": 153 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that regulatory action (FDA Drug Enforcement Actions " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0061", "drug": "norethindrone acetate and ethinyl estradiol", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 7452.989816665649, "track_a": { "text": "Yes, there has been regulatory action on norethindrone acetate and ethinyl estradiol. **Doc 5** and **Doc 6** document an active FDA Drug Enforcement Action (effective 2017-01-30) for Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, manufactured by Mylan Pharmaceuticals, due to chemical contamination resulting in out-of-specification impurities. This product recall remains currently active.", "input_tokens": 2421, "output_tokens": 121 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the FDA Drug " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0062", "drug": "ibuprofen", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4187.798023223877, "track_a": { "text": "**Yes, there has been regulatory action on ibuprofen.**\n\nMultiple ACTIVE recalls are documented: Doc 5 and Doc 6 show an ACTIVE Class II recall (D-0583-2018) for Ibuprofen Tablets USP 200 mg due to CGMP deviations, and Doc 8 shows an ACTIVE recall (effective 2020-03-16) for Ibuprofen-containing Advil Allergy & Congestion Relief due to labeling deficiencies. Additionally, Doc 7 documents an ACTIVE recall (D-0347-2025) for a combination product containing ibuprofen due to CGMP deviations.", "input_tokens": 2095, "output_tokens": 158 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0063", "drug": "desoximetasone", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4502.558946609497, "track_a": { "text": "Yes, there has been regulatory action on desoximetasone. **Doc 3 and Doc 4** (both marked ACTIVE) document an FDA Class II recall of Desoximetasone Cream USP 0.25% due to failed stability specifications\u2014specifically, out-of-specification results for the homogeneity test showing moderate separation (Recall number D-0116-2017, effective 2016-09-13). While desoximetasone itself remains an approved drug class, these specific lots were subject to enforcement action.", "input_tokens": 2815, "output_tokens": 122 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0064", "drug": "dofetilide", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4274.781227111816, "track_a": { "text": "Yes, there has been regulatory action on dofetilide. **Doc 2 and Doc 3** both document an active FDA Drug Enforcement Action (Recall number D-0384-2023, Class II) for Dofetilide Capsules 250 mcg manufactured by Intas Pharmaceuticals Limited, citing CGMP Deviations following an FDA inspection. The recall remains currently active as of the document effective date of 2023-02-07.", "input_tokens": 3224, "output_tokens": 109 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0065", "drug": "dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5044.019937515259, "track_a": { "text": "Yes, there has been regulatory action. The ingredient combination of dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, and magnesium chloride appears in **Doc 2 (RECALLED as of 2010-01-01)** and **Doc 5 (currently ACTIVE as of 2020-04-14)**. While an active label exists, the prior recall in Doc 2 indicates regulatory action was taken on this formulation. The current active status in Doc 5 suggests the product may have been reformulated or reapproved, but the historical recall should be noted.", "input_tokens": 2925, "output_tokens": 138 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the recall (\"" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0066", "drug": "atorvastatin calcium", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4812.001943588257, "track_a": { "text": "**Yes, there has been regulatory action on atorvastatin calcium.**\n\nA recalled atorvastatin calcium product (NDC 0093-5054-01) was subject to a Class II recall effective August 15, 2024, due to nitrosamine impurity exceeding acceptable daily intake limits (Doc 1, Recall D-3210-2024). While atorvastatin calcium remains an FDA-approved drug class, this specific product formulation was removed from the market due to safety concerns.", "input_tokens": 2255, "output_tokens": 115 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the recall (C" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0067", "drug": "alprazolam", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4387.979745864868, "track_a": { "text": "Yes, there has been regulatory action on alprazolam. **Doc 2 and Doc 3** (both ACTIVE as of 2022-04-28) document an FDA Class II recall of alprazolam XR extended-release tablets, 3 mg (Recall D-0844-2022) distributed by Greenstone LLC due to failed dissolution specifications with low out-of-specification dissolution test results. This indicates the product was subject to an enforcement action, though the drug itself remains approved\u2014this specific batch/formulation was recalled for quality defects.", "input_tokens": 2480, "output_tokens": 126 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0068", "drug": "duloxetine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5237.508058547974, "track_a": { "text": "Yes, there has been regulatory action on duloxetine. **Doc 4 and Doc 5** show an active FDA Drug Enforcement Action (Class III recall, D-0097-2018) for Duloxetine Delayed-Release Capsules USP 30 mg manufactured by Lupin Limited, due to failed dissolution specifications. The recall remains currently active as of the document effective date (2017-11-21).", "input_tokens": 3149, "output_tokens": 98 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0069", "drug": "pramipexole dihydrochloride", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4399.511098861694, "track_a": { "text": "Yes, there has been regulatory action on pramipexole dihydrochloride. **Doc 3** shows an active FDA Drug Enforcement Action (Recall number D-1851-2019, Class III) for Pramipexole Dihydrochloride Tablets 0.125 mg due to subpotent drug\u2014out of specification results during stability testing. The recall remains currently active as of the document's effective date of 2019-08-21.", "input_tokens": 2910, "output_tokens": 110 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0070", "drug": "fluorescein", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3684.1537952423096, "track_a": { "text": "Yes, there has been regulatory action on fluorescein. **Doc 2** shows an active FDA Drug Enforcement Action (effective 2021-04-13) for Fluorescein Sodium Ophthalmic Strips USP (0.12mg), manufactured by Nomax, Inc., recalled due to subpotency (Recall number D-0387-2021, Class III classification). This indicates regulatory action has been taken against this fluorescein product.", "input_tokens": 3236, "output_tokens": 105 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0071", "drug": "tattoo numbing spray", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3746.055841445923, "track_a": { "text": "Yes, there has been regulatory action. **Doc 3 and Doc 4** show that Pro Numb Tattoo Numbing Spray (5% Lidocaine) is subject to an active FDA Drug Enforcement Action (Recall number D-0302-2026, Class II) due to cGMP deviations. The product is not currently approved for distribution.", "input_tokens": 2588, "output_tokens": 86 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0072", "drug": "levothyroxine, liothyronine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4535.576820373535, "track_a": { "text": "Yes, there has been regulatory action on levothyroxine and liothyronine products. **Levothyroxine Sodium Tablets USP 150 mcg** (Mylan) has an active Class II recall (Doc 3-4, effective 2024-11-18) due to potency failures (superpotent and subpotent drug). **Liothyronine Sodium Tablets USP 5 mcg** (Sun Pharmaceutical) has an active Class II recall (Doc 2 & 5, effective 2023-12-04) due to failed impurities/degradation specifications. Both drugs remain FDA-approved but specific batches are subject to ongoing enforcement actions.", "input_tokens": 2148, "output_tokens": 163 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 recalls/" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0073", "drug": "chlorpheniramine maleate 4mg", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4002.089023590088, "track_a": { "text": "Yes, there has been regulatory action on chlorpheniramine maleate 4 mg. **Doc 7 and Doc 8** (both ACTIVE as of 2024-10-21) document an FDA Class II recall of Chlorpheniramine Maleate 4 mg tablets manufactured for Athlete's Needs due to stability failure and superpotent drug concerns (Recall D-0029-2025). Additionally, **Doc 9** (ACTIVE as of 2019-07-11) and **Doc 10** (ACTIVE as of 2020-03-16) document recalls of combination products containing chlorpheniramine maleate due to superpotency/failed stability and labeling deficiencies, respectively.", "input_tokens": 2026, "output_tokens": 170 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0074", "drug": "bupivacaine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4382.997035980225, "track_a": { "text": "Yes, there has been regulatory action on bupivacaine. Multiple ACTIVE recalls are documented: Doc 5 and Doc 6 (Class I recall for particulate matter in 0.25% Bupivacaine HCl Injection, effective 2013-07-12), and Doc 7 (Class I recall for Sensorcaine bupivacaine with epinephrine due to subpotent epinephrine, effective 2022-11-22). While bupivacaine remains an approved drug, these specific products have been subject to FDA enforcement actions.", "input_tokens": 2906, "output_tokens": 134 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 multiple FDA" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0075", "drug": "calcipotriene and betamethasone dipropionate", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4258.9380741119385, "track_a": { "text": "Based on the documents, **calcipotriene and betamethasone dipropionate (Taclonex) has had regulatory action, but the product remains currently active**.\n\nDocuments 3 and 4 show that Taclonex topical suspension 0.005%/0.064% is marked as \"currently ACTIVE\" with an effective date of 2017-01-16. The regulatory action involved a labeling issue\u2014the product was packaged with an out-of-date package insert. This is a Class II recall for labeling deficiency, not a withdrawal of approval. The drug itself remains FDA-approved and distributed; the enforcement action addressed the packaging/labeling problem.", "input_tokens": 3151, "output_tokens": 154 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0076", "drug": "paricalcitol", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3442.5671100616455, "track_a": { "text": "Yes, there has been regulatory action on paricalcitol. **Zemplar (paricalcitol) capsules, 1 mcg** were subject to an FDA Class III recall (Recall number D-0833-2016, effective March 24, 2016) due to failed content uniformity specifications (Docs 1-2). This indicates a regulatory enforcement action against this product.", "input_tokens": 2841, "output_tokens": 92 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies that paricalcitol (Zemplar) was subject to FDA regula" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0077", "drug": "nilotinib", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4094.58589553833, "track_a": { "text": "Based on the documents, **nilotinib has had regulatory action taken**. Documents 4 and 5 show FDA Drug Enforcement Actions for Nilotinib Capsules (150 mg) manufactured by Cipla Ltd., with a reason for recall listed as \"Failed Tablet/Capsule Specifications\" (Recall number D-3210-2024, effective 2024-08-15). Although these documents are marked \"currently ACTIVE,\" the presence of an FDA enforcement action indicates regulatory action has been taken against this product.", "input_tokens": 2610, "output_tokens": 121 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies that nilotin" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0078", "drug": "onion, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, sulfur, ambrosia artemisiifolia whole, euphrasia stricta and schoenocaulon officinale seed", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4095.952033996582, "track_a": { "text": "Yes, there has been regulatory action. **Doc 1** shows a RECALLED label for this exact drug combination effective 2010-01-01. However, **Doc 7** presents a currently ACTIVE label for the identical ingredient combination effective 2024-12-12, indicating the drug was re-approved after the earlier recall. The drug is currently approved by the FDA.", "input_tokens": 3442, "output_tokens": 83 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 claims the drug \"is currently ap" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0079", "drug": "ketorolac tromethamine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 6344.423055648804, "track_a": { "text": "Yes, there has been regulatory action on Ketorolac Tromethamine Injection. **Doc 4 and Doc 5** show an active FDA Drug Enforcement Action (Recall number D-1274-2019, Class II) for Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL, due to lack of sterility assurance with microbial growth detected during manufacturing process simulation. This recall remains currently active as of the document effective date (2019-04-30).", "input_tokens": 2706, "output_tokens": 123 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0080", "drug": "metformin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 12495.399236679077, "track_a": { "text": "Yes, there has been regulatory action on metformin products. Multiple FDA recalls are documented:\n\n- **Doc 1** (RECALLED): Metformin Hydrochloride Tablets (NDC 0093-1058-01) recalled for nitrosamine impurity exceeding FDA limits (D-2074-2024).\n- **Doc 3** (ACTIVE recall): Metformin HCl Extended-Release Tablets 750 mg recalled for NDMA impurity above acceptable levels (D-1386-2020).\n- **Doc 4** (ACTIVE recall): Metformin HCl Extended-Release Tablets 500 mg recalled for failed moisture limits (D-0325-2021).\n\nAdditionally, combination products containing metformin (Xigduo XR, Synjardy XR, Jentadueto XR) have active recalls for CGMP deviations. While metformin remains an FDA-approved drug, multiple specific batches and formulations have been subject to enforcement actions.", "input_tokens": 2215, "output_tokens": 235 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 multiple FDA" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0081", "drug": "cysteine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4281.513929367065, "track_a": { "text": "Based on the documents provided, **cysteine has been subject to regulatory action**. Doc 2 and Doc 3 show that ELCYS (cysteine hydrochloride injection), USP 500 mg/10mL, manufactured by Exela Pharma Sciences, LLC, was recalled effective October 18, 2023 (Recall number D-0118-2024, Class I) due to the presence of particulate matter (silicone). These documents are marked as currently ACTIVE, indicating the recall remains in effect.", "input_tokens": 3077, "output_tokens": 124 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0082", "drug": "thyroid, porcine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3559.2968463897705, "track_a": { "text": "Yes, there has been regulatory action on porcine thyroid products. **NP Thyroid 60** (a porcine thyroid product manufactured by Acella Pharmaceuticals) was recalled as a Class I enforcement action due to being superpotent (Doc 1, Recall D-1299-2020). Additionally, **Armour Thyroid 2 grain** (also a porcine thyroid product) was recalled as a Class II action due to CGMP deviations involving improper storage temperature exposure (Doc 2, Recall D-0168-2024). These recalls indicate significant regulatory concerns with porcine thyroid products.", "input_tokens": 2051, "output_tokens": 148 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies and documents specific FDA regulatory actions (recall" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0083", "drug": "fulvestrant", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3829.052209854126, "track_a": { "text": "**Yes, there has been regulatory action on fulvestrant.** Documents 3 and 4 show an active FDA Drug Enforcement Action (Recall number D-0820-2021, Class II) for Fulvestrant Injection 250 mg/5 mL due to \"Lack of Assurance of Sterility,\" effective August 27, 2021. While the document is marked \"ACTIVE,\" this indicates an ongoing enforcement action rather than standard approval.", "input_tokens": 3143, "output_tokens": 107 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0084", "drug": "trazodone", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4811.399221420288, "track_a": { "text": "Yes, trazodone has had regulatory action. **Doc 4 and Doc 5** show active FDA Drug Enforcement Actions (recalls) for traZODONE Hydrochloride Tablets, USP, 100mg, effective 2025-12-19. The recall (Class III) was issued due to failed tablet specifications\u2014some tablets had dents on the surface. While the product remains approved for use, there is an ongoing active recall for this specific batch/formulation.", "input_tokens": 3126, "output_tokens": 111 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 trazod" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0085", "drug": "diazepam", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3467.756986618042, "track_a": { "text": "Yes, there has been regulatory action on diazepam. **Doc 2 and Doc 3** (both ACTIVE as of 2013-02-26) document an FDA Class II recall of Diazepam Injection, USP 5 mg/mL due to lack of assurance of sterility caused by a loose crimp on the fliptop vial (Recall number D-313-2013). While diazepam as a drug entity remains FDA-approved, this specific product formulation was subject to enforcement action.", "input_tokens": 2392, "output_tokens": 122 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the FDA Class" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0086", "drug": "azelastine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3795.203924179077, "track_a": { "text": "**Yes, there has been regulatory action on azelastine products.**\n\nAzelastine HCl Nasal Solution 0.1% (Docs 5\u20136) has an active FDA recall effective 2018-02-05 due to failure to meet droplet size requirements. Additionally, Dymista (azelastine hydrochloride/fluticasone propionate) has an active Class II recall (Doc 7, effective 2019-02-01) for potential broken glass in bottle necks. These are currently active enforcement actions, not historical recalls.", "input_tokens": 2561, "output_tokens": 131 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0087", "drug": "aflibercept", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3996.497869491577, "track_a": { "text": "Yes, there has been regulatory action on aflibercept. **Doc 2 and Doc 3** show that EYLEA (aflibercept) Injection 2 mg has an active FDA Drug Enforcement Action (Recall number D-0531-2024, Class II) due to lack of assurance of sterility and complaints of syringe breakage, effective as of May 15, 2024. While aflibercept may retain FDA approval, this current recall indicates ongoing regulatory concerns with specific lots of this product.", "input_tokens": 2908, "output_tokens": 119 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0088", "drug": "iodinated i-131 albumin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4300.648927688599, "track_a": { "text": "Yes, there has been regulatory action on Iodinated I-131 Albumin. **Doc 3 and Doc 4** show an active FDA Drug Enforcement Action (Class II recall, D-1008-2019, effective 2019-03-11) for Volumex (Iodinated I-131 Albumin) Injection due to lack of assurance of sterility from environmental monitoring failures. This product is currently subject to recall and is not approved for distribution.", "input_tokens": 2470, "output_tokens": 110 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\nThe answer correctly identifies and mentions the FDA regulatory action (Class II reca" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0089", "drug": "ramipril", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3378.1418800354004, "track_a": { "text": "Yes, there has been regulatory action on Ramipril. **Docs 4 and 5** show an active FDA Drug Enforcement Action (Recall D-0054-2025, Class II) for Ramipril Capsules USP 10 mg manufactured by Lupin Limited due to cGMP deviations\u2014the active pharmaceutical ingredient was sourced from an unapproved vendor. This recall remains currently active as of October 23, 2024.", "input_tokens": 3087, "output_tokens": 107 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0090", "drug": "nitroglycerin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 5016.113996505737, "track_a": { "text": "Yes, there has been regulatory action on Nitroglycerin Lingual Spray. **Doc 7 and Doc 8** (both marked ACTIVE) document an FDA Drug Enforcement Action (Recall D-0372-2022, Class II) for Nitroglycerin Lingual Spray 400 mcg due to a defective delivery system. The product remains under active recall status as of the document effective date of 2021-12-27.", "input_tokens": 2640, "output_tokens": 107 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer correctly identifies and mentions" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0091", "drug": "isotretinoin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3481.459856033325, "track_a": { "text": "Based on the documents provided, **isotretinoin has had regulatory action taken against it**. Doc 4 shows an ACTIVE FDA Drug Enforcement Action for Zenatane (isotretinoin) capsules, 10 mg, with a Class III recall (D-0509-2017) due to failed dissolution specifications. This indicates a specific batch/product recall, though isotretinoin as a drug class remains FDA-approved; this particular formulation experienced regulatory enforcement action.", "input_tokens": 2657, "output_tokens": 107 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 isotre" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0092", "drug": "drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3684.3032836914062, "track_a": { "text": "Yes, there has been regulatory action. Drospirenone, ethinyl estradiol and levomefolate calcium (Tydemy) was subject to an FDA recall effective June 23, 2023, due to failed stability specifications and failed impurities (Docs 4 and 5). While the product may retain FDA approval status, the active enforcement action indicates significant regulatory concerns regarding product quality and safety.", "input_tokens": 2437, "output_tokens": 94 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 recall effect" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0093", "drug": "buspirone", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3758.246898651123, "track_a": { "text": "Yes, there has been regulatory action on buspirone. **Doc 2 and Doc 3** show active FDA Drug Enforcement Actions (Class II recalls) effective February 7, 2023, for BusPIRone Hydrochloride Tablets USP 30 mg due to CGMP deviations following an FDA inspection (Recall number D-0379-2023). Additionally, **Doc 1** is a recalled document from 2010 also referencing meclizine hydrochloride labeling issues. Buspirone is not currently without regulatory concerns.", "input_tokens": 3263, "output_tokens": 132 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0094", "drug": "hydroxyzine pamoate", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3611.7513179779053, "track_a": { "text": "Yes, there has been regulatory action on hydroxyzine pamoate. **Doc 5 and Doc 6** (both currently ACTIVE) document an FDA Class II recall of Teva Hydroxyzine Pamoate Capsules, USP, 100 mg due to CGMP deviations\u2014the API was incorrectly released for use in manufacturing (Recall number D-1093-2014, effective 2014-01-24). This indicates the product was subject to enforcement action, though the drug ingredient itself remains FDA-approved for use when manufactured properly.", "input_tokens": 2787, "output_tokens": 129 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_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 FDA Clas" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0095", "drug": "chlorhexidine gluconate and isopropyl alcohol", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3957.3960304260254, "track_a": { "text": "Yes, there has been regulatory action. **Doc 5 and Doc 7** show an active FDA Drug Enforcement Action (effective 2023-08-25) for BD ChloraPrep Clear, which contains 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol. Additionally, **Doc 6** documents an active Class I recall (effective 2016-07-29) for 2% Chlorhexidine Gluconate Cloth due to CGMP deviations and potential contamination. These products are subject to ongoing regulatory enforcement actions, not simple approval.", "input_tokens": 2579, "output_tokens": 141 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0096", "drug": "rifampin", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 6177.806854248047, "track_a": { "text": "Yes, there has been regulatory action on Rifampin. **Doc 3** shows an active FDA Drug Enforcement Action (Recall number D-1343-2022, Class II) for Rifampin Capsules USP 150 mg manufactured by Lupin Pharmaceuticals due to CGMP deviations involving out-of-specification results for 1-Methyl-4-Nitroso Piperazine (MNP) impurity, effective July 28, 2022. This indicates the product was subject to a recall, though the document is marked \"currently ACTIVE\" as an enforcement action.", "input_tokens": 3120, "output_tokens": 142 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the FDA Drug " }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0097", "drug": "amlodipine besylate and benazepril", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 3584.2442512512207, "track_a": { "text": "Yes, there has been regulatory action on amlodipine and benazepril HCl capsules. **Doc 3 and Doc 4** show an active FDA Drug Enforcement Action (Recall D-0542-2025, Class II) issued on 2025-07-02 for Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg manufactured by Lupin Pharmaceuticals due to incorrect expiry dating (released with Feb.2027 instead of Jan.2027).", "input_tokens": 2764, "output_tokens": 129 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0\n\n**Reasoning:**\n- **currency_correct=1**: The answer explicitly mentions the FDA regul" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0098", "drug": "ranolazine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 4679.821014404297, "track_a": { "text": "Yes, there has been regulatory action on ranolazine. **Doc 2 and Doc 3** show active FDA Drug Enforcement Actions (Class II recalls) for Ranolazine Extended-Release Tablets 1000mg manufactured by Glenmark Pharmaceuticals, effective March 13, 2025, due to CGMP Deviations (Recall number D-0335-2025). This indicates the product has been recalled, though ranolazine as a drug entity remains FDA-approved for use; this specific product batch/manufacturer has been subject to enforcement action.", "input_tokens": 3041, "output_tokens": 130 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } }, { "pair_id": "fda_0099", "drug": "meclizine", "hybrid": { "used_hybrid": false }, "track_a_latency_ms": 6789.116144180298, "track_a": { "text": "Yes, there has been regulatory action on meclizine. Two active FDA Drug Enforcement Actions are currently in effect:\n\n1. **Doc 6 & 7** (effective 2019-10-01): Motion Sickness (meclizine hydrochloride) 25 mg tablets distributed by Sato Pharmaceutical were recalled for being subpotent (Recall D-0323-2020, Class III).\n\n2. **Doc 8** (effective 2022-03-08): Meclizine Hydrochloride Tablets USP 12.5 mg manufactured by Jubilant Cadista Pharmaceuticals were recalled due to a labeling mix-up where bottles were incorrectly labeled as PredniSONE.\n\nBoth recalls remain active, indicating ongoing regulatory concerns with specific meclizine products.", "input_tokens": 2452, "output_tokens": 190 }, "track_b_latency_ms": 0.0, "track_b": { "text": "", "input_tokens": 0, "output_tokens": 0, "_skipped": true }, "track_a_score": { "currency_correct": 1, "anchor_leak": 0, "judge_text": "currency_correct=1 anchor_leak=0" }, "track_b_score": { "currency_correct": 0, "anchor_leak": 0, "_skipped": true } } ] }