Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 167...
FDA Recall #D-0415-2023 — Class II — February 7, 2023
Product Description
Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling Firm
Accord Healthcare, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,113,264 bottles
Distribution
United States including Puerto Rico and Canada
Code Information
Batches: a) P2002450, Exp. Date 4/30/2023, P2003222, Exp. Date 5/31/2023; P2003223, Exp. Date 5/31/2023; P2003224, Exp. Date 5/31/2023; P2004636, Exp. Date 8/31/2023; P2005035, Exp. Date 8/31/2023; P2005038, Exp. Date 8/31/2023; P2005040, Exp. Date 8/31/2023; P2005039, Exp. Date 8/31/2023; P2005041, Exp. Date 8/31/2023; P2005606, Exp. Date 9/30/2023; P2100340, Exp. Date 9/30/2023; P2100009, Exp. Date 12/31/2023; P2100010, Exp. Date 12/31/2023; P2100044, Exp. Date 12/31/2023; P2100045, Exp. Date 12/31/2023; P2100046, Exp. Date 12/31/2023; P2101129, Exp. Date 1/31/2024; P2101880, Exp. Date 1/31/2024; P2101130, Exp. Date 1/31/2024; P2101131, Exp. Date 1/31/2024; P2106689, Exp. Date 9/30/2024; P2106691, Exp. Date 9/30/2024; P2203585, Exp. Date 6/30/2025; b) P2002451 Exp. Date 4/30/2023; P2005365, Exp. Date 8/31/2023; P2005036, Exp. Date 8/31/2023; P2005037, Exp. Date 8/31/2023; P2005607, Exp. Date 9/30/2023; P2005608, Exp. Date 9/30/2023; P2100048, Exp. Date 12/31/2023; P2100052, Exp. Date 12/31/2023; P2100053, Exp. Date 12/31/2023; P2100055, Exp. Date 12/31/2023; P2100054, Exp. Date 12/31/2023; P2100387, Exp. Date 12/31/2023; P2100526, Exp. Date 12/31/2023; P2100525, Exp. Date 12/31/2023; P2100528, Exp. Date 12/31/2023; P2100530, Exp. Date 12/31/2023; P2100532, Exp. Date 12/31/2023; P2100531, Exp. Date 12/31/2023; P2100533, Exp. Date 12/31/2023; P2101127, Exp. Date 1/31/2024; P2101128, Exp. Date 1/31/2024; P2106094, Exp. Date 8/31/2024; P2106091, Exp. Date 8/31/2024; P2106093, Exp. Date 8/31/2024; P2200039, Exp. Date 9/30/2024; P2107771, Exp. Date 11/30/2024; P2107774, Exp. Date 11/30/2024; P2107772, Exp. Date 11/30/2024; P2200505, Exp. Date 12/31/2024; P2200506, Exp. Date 12/31/2024; P2200503, Exp. Date 12/31/2024; P2200510, Exp. Date 12/31/2024; P2200508, Exp. Date12/31/2024; P2203056, Exp. Date 5/31/2025; P2203058, Exp. Date 5/31/2025; P2203060, Exp. Date 5/31/2025; P2203057, Exp. Date 5/31/2025; P2203059, Exp. Date 5/31/2025; P2203584, Exp. Date 6/30/2025; P2205372, Exp. Date 8/31/2025; P2205376, Exp. Date 8/31/2025;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated