FDA-Drug2025-06-11Class II
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
Torrent Pharma Inc.
Hazard
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Sold states
U.S. Nationwide.
Affected count
3672 Bottles
Manufactured in
106 Allen Rd Ste 305, N/A, Basking Ridge, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0455-2025Don't want to check this manually?
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