FDA-Drug2025-06-18Class I
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.
Amneal Pharmaceuticals, LLC
Hazard
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Sold states
Nationwide in the USA
Affected count
6396 bottles
Manufactured in
400 Crossing Blvd Fl 3, Bridgewater, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0488-2025Don't want to check this manually?
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