Drug recall D-0456-2025
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 for recall
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Lots and codes
Lot# BDX6K001; Exp. Date: 06/30/2025
Recall details
- Recalling firm
- Torrent Pharma Inc., Basking Ridge, NJ
- Quantity
- 972 Cartons
- Distribution
- U.S. Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 27, 2025
Related products
- Fluoxetine – drug information
- NDC 13668-443 Fluoxetine · Fluoxetine Hydrochloride 10 mg/1 · Torrent Pharmaceuticals Limited
- NDC 13668-473 Fluoxetine · Fluoxetine Hydrochloride 20 mg/1 · Torrent Pharmaceuticals Limited