Drug recall D-0654-2025
Product
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.
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 #: a) F118062503, Exp Date 05/31/2027, F118062507, Exp Date. 07/31/2027. b) F118062504, F118062505, Exp. Date 05/31/2027; F118062509, Exp. Date. 08/31/2027; F118062512, Exp. Date 04/30/2027. c) F118062506, Exp. Date 06/30/2027. d) F118062423, Exp. Date 01/31/2027; F118062501, Exp. Date 06/30/2027; F118062502, Exp. Date 04/30/2027; F118062508, Exp. Date 08/31/2027.
Recall details
- Recalling firm
- Northwind Pharmaceuticals LLC, Indianapolis, IN
- Quantity
- a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 20, 2025
Related products
- Sulfamethoxazole and Trimethoprim – drug information
- NDC 51655-307 Sulfamethoxazole and Trimethoprim · Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 · Northwind Health Company, LLC