Product: Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Reason for recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Recall initiated: 20251006
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated