Drug product
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
D-0624-2025
Product summary
- Event
- Event 97523
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0624-2025
Official wording
Reason: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Code information: Lot # N02309, Exp 03/31/2027
Distribution pattern: USA Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance