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
Status
Ongoing
Lot
Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Amneal Pharmaceuticals, LLC — Class II Recall | MedicineWatch US