FDAHealthMay 27, 2025
Torrent Pharma Inc. — 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., Baskin
⚠️ CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 27, 2025
U.S. Nationwide.
What's affected?
- 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)
- Brand
- FLUOXETINE
- UPC
- 0313668443301
- Lot code
- BDX6K001
Additional details
Lot# BDX6K001; Exp. Date: 06/30/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 972 Cartons.
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