Class II
Ongoing
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30
This recall is currently active, issued June 11, 2025. It was issued by Torrent Pharma Inc..
- Company
- Torrent Pharma Inc.
- Recall Initiated
- May 27, 2025
- Posted
- June 11, 2025
- Recall Number
- D-0455-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3672 Bottles
- Firm Location
- Basking Ridge, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Distribution
U.S. Nationwide.
Lot / Code Info
Lot# BDX6K001; Exp. Date 06/30/2025
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