Accord Healthcare, Inc.: Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-count bottles NDC 16729-090-15 UPC 3 16729 09015 5; c) 100

Hazard

CGMP Deviations: recalling drug products following an FDA inspection.

Details from the source

Reason for recall: CGMP Deviations: recalling drug products following an FDA inspection. Distribution: United States including Puerto Rico and Canada Quantity: 2,731,365 bottles Lot/code info: Batches: a) P2001383, Exp. Date 2/28/2023; P2004886, Exp. Date 8/31/2023; P2100853, Exp. Date 11/30/2023; P2101652, Exp. Date 2/29/2024; P2101821, Exp. Date 2/29/2024; P2102146, Exp. Date 3/31/2024; P2107270, Exp. Date 10/31/2024; P2107939, Exp. Date 10/31/2024; P2201491, Exp. Date 2/28/2025; b) P2001377, Exp. Date 2/28/2023; P2005673, Exp. Date 9/30/2023; P2005911, Exp. Date 10/31/2023; P2005878, Exp. Date 10/31/2023; P2006076, Exp. Date 10/31/2023; P2006110,Exp. Date 10/31/2023; P2006830, Exp. Date 11/30/2023; P2100639, Exp. Date 1/31/2024; P2100640, Exp. Date 1/31/2024; P2104208, Exp. Date 6/30/2024; P2105388, Exp. Date 7/31/2024; P2105387, Exp. Date 7/31/2024; P2200316, Exp. Date 12/31/2024; P2200318, Exp. Date 12/31/2024; P2200317, Exp. Date 12/31/2024; P2200319, Exp. Date 12/31/2024; P2200820, Exp. Date 1/31/2025; P2200822, Exp. Date 1/31/2025; P2201492, Exp. Date 2/28/2025; P2201493, Exp. Date 2/28/2025; P2201758, Exp. Date 2/28/2025; P2201759, Exp. Date 2/28/2025; P2202107, Exp. Date 3/31/2025; c) P2001375, Exp. Date 2/28/2023; P2003258, Exp. Date 5/31/2023; P2005402, Exp. Date 9/30/2023; P2005497, Exp. Date 9/30/2023; P2100511, Exp. Date 12/31/2023; P2101047, Exp. Date 1/31/2024; P2104753, Exp. Date 6/30/2024; P2105389, Exp. Date 7/31/2024; P2107273, Exp. Date 10/31/2024; P2107276, Exp. Date 10/31/2024; P2107419, Exp. Date 10/31/2024; P2201757, Exp. Date 2/28/2025; d)P2001376, Exp. Date 2/28/2023; P2002182, Exp. Date 3/31/2023; P2002184, Exp. Date 3/31/2023; P2003254

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.