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)
Reported: June 11, 2025 Initiated: May 27, 2025 #D-0456-2025
Product Description
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.
Details
- Recalling Firm
- Torrent Pharma Inc.
- Units Affected
- 972 Cartons
- Distribution
- U.S. Nationwide.
- Location
- Basking Ridge, NJ
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Torrent Pharma Inc.. Units affected: 972 Cartons.
Why was this product recalled? ▼
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 11, 2025. Severity: Moderate. Recall number: D-0456-2025.
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