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FDARecalled Jun 18, 2025 · #D-0488-2025

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 Pharmaceut...

Hazard

Class I — serious health risk

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Description

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. Classification: Class I Distribution: Nationwide in the USA

Product details

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.
Type
Drugs
Manufacturer
Amneal Pharmaceuticals, LLC
Model numbers
UPCs