Class II
Ongoing
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
This recall is currently active, issued September 17, 2025. It was issued by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories.
- Recall Initiated
- September 2, 2025
- Posted
- September 17, 2025
- Recall Number
- D-0624-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
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.
Distribution
USA Nationwide.
Lot / Code Info
Lot # N02309, Exp 03/31/2027
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