FDARecalled Jun 11, 2025 · #D-0456-2025
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. ...
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. Classification: Class II Distribution: U.S. Nationwide.
Product details
- 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)
- Type
- Drugs
- Manufacturer
- Torrent Pharma Inc.
- Model numbers
- BDX6K001
- UPCs
- —