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Torrent Pharma Inc. Recall: Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose

Torrent Pharma Inc. Recall: Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Torrent Pharma Inc.; Product: Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad

Recalling firmTorrent Pharma Inc.
ProductFluoxetine 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 recallCGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionU.S. Nationwide.
Recall initiated20250527
Recall numberD-0456-2025
Categorydrug
StateNJ
CountryUnited States

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