Drug 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)
D-0456-2025
Product summary
- Event
- Event 96983
- Status
- Completed
- Classification
- Class II
- Quantity
- 972 Cartons
- Official record key
drug-enforcement:D-0456-2025
Official wording
Reason: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Code information: Lot# BDX6K001; Exp. Date: 06/30/2025
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations