MedicineWatch US
Class II Recall

Torrent Pharma Inc.

Product
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
Reason
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Classification
Class II
Status
Completed
Lot
Lot# BDX6K001; Exp. Date: 06/30/2025
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.
Torrent Pharma Inc. — Class II Recall | MedicineWatch US