Drug Enforcement D-0456-2025

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

Status

Ongoing

Classification

Class II

Report Date

June 11, 2025

Termination Date

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Product Information

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)
Product quantity
972 Cartons
Reason for recall
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
U.S. Nationwide.

Location & Firm

Recalling firm
Torrent Pharma Inc.
Address
106 Allen Rd Ste 305, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0456-2025
Event ID
96983
Recall initiation date
May 27, 2025
Center classification date
June 2, 2025
Code info
Lot# BDX6K001; Exp. Date: 06/30/2025
More code info
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