Drug product
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
D-0488-2025
Product summary
- Event
- Event 96985
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 6396 bottles
- Official record key
drug-enforcement:D-0488-2025
Official wording
Reason: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Code information: Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial contamination