Product: 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.
Recall initiated: 20250527
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated