Drug recall D-0624-2025
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
Reason for recall
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.
Lots and codes
Lot # N02309, Exp 03/31/2027
Recall details
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN
- Quantity
- N/A
- Distribution
- USA Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 2, 2025
Related products
- Sulfamethoxazole and Trimethoprim – drug information
- NDC 0904-2725 Sulfamethoxazole and Trimethoprim · Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 · Major Pharmaceuticals