Drug recall D-0625-2025
Product
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).
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
Bag: N02309A and N02309B, Exp Date: 03/31/2027; Inner blister: Lot # N02309, Exp Date: 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
- NDC 55154-7895 Sulfamethoxazole and Trimethoprim · Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 · Cardinal Health 107, LLC