FDARecalled Apr 8, 2026 · #D-0408-2026
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glas...
Hazard
Class II — temporary health risk
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Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH). Classification: Class II Distribution: Nationwide within the USA
Product details
- Product
- traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.
- Type
- Drugs
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Model numbers
- AM230987
- UPCs
- —