Drug 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.

D-0408-2026

March 19, 2026

Class II

Product summary

Firm: Amneal Pharmaceuticals, LLC
Event: Event 98623
Status: Ongoing
Classification: Class II
Quantity: 29,542 bottles
Official record key: drug-enforcement:D-0408-2026

Official wording

Reason: 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).

Code information: Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.

Distribution pattern: Nationwide within the USA

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity
Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Impurities/Degradation Specifications