Home / Recalls / Torrent Pharma Inc. / D-0455-2025

D-0455-2025 Class II Ongoing

Recalled by Torrent Pharma Inc. — Basking Ridge, NJ

Recall Details

Product Type: Drugs
Report Date: June 11, 2025
Initiation Date: May 27, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3672 Bottles

Product Description

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

Reason for Recall

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

Distribution Pattern

U.S. Nationwide.

Code Information

Lot# BDX6K001; Exp. Date 06/30/2025

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