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Drug Enforcement D-0392-2023

CGMP Deviations: recalling drug products following an FDA inspection.

Status

Terminated

Classification

Class II

Report Date

March 8, 2023

Termination Date

April 22, 2024

Product Information

Product description: 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-count bottles NDC 16729-090-01 UPC 3 16729 09001 8; d) 500-count bottles NDC 16729-090-16 UPC 3 16729 09016 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Product quantity: 2,731,365 bottles
Reason for recall: CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiation reason: —
Initial firm notification: Letter
Distribution pattern: United States including Puerto Rico and Canada

Location & Firm

Recalling firm: ACCORD HEALTHCARE, INC.
Address: 1009 Slater Rd Ste 210B, N/A

United States
Voluntary / Mandated: Voluntary: Firm initiated
Status date: —

Codes & Dates

Recall number: D-0392-2023
Event ID: 91657
Recall initiation date: February 7, 2023
Center classification date: March 2, 2023
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, Exp. Date 5/31/2023; P2003255, Exp. Date 5/31/2023; P2003256, Exp. Date 5/31/2023; P2003257, Exp. Date 5/31/2023; P2004403, Exp. Date 7/31/2023; P2004404, Exp. Date 7/31/2023; P2004416, Exp. Date 7/31/2023; P2004417, Exp. Date 7/31/2023; P2004526, Exp. Date 7/31/2023; P2004527, Exp. Date 7/31/2023; P2004841, Exp. Date 8/31/2023; P2004842, Exp. Date 8/31/2023; P2004885, Exp. Date 8/31/2023; P2004899, Exp. Date 8/31/2023; P2004901, Exp. Date 8/31/2023; P2005406, Exp. Date 9/30/2023; P2005498, Exp. Date 9/30/2023; P2005671, Exp. Date 9/30/2023; P2005675, Exp. Date 9/30/2023; P2005672, Exp. Date 9/30/2023; P2005860, Exp. Date 10/31/2023; P2006077, Exp. Date 10/31/2023; P2006079, Exp. Date 10/31/2023; P2006125, Exp. Date 10/31/2023; P2006081, Exp. Date 10/31/2023; P2006111, Exp. Date 10/31/2023; P2006832, Exp. Date 11/30/2023; P2006831, Exp. Date 11/30/2023; P2006833, Exp. Date 11/30/2023; P2006834, Exp. Date 11/30/2023; P2006835, Exp. Date 11/30/2023; P2100266, Exp. Date 12/31/2023; P2100268, Exp. Date 12/31/2023; P2100269, Exp. Date 12/31/2023; P2100637, Exp. Date 1/31/2024; P2100636, Exp. Date 1/31/2024; P2100638, Exp. Date 1/31/2024; P2100795, Exp. Date 1/31/2024; P2100797, Exp. Date 1/31/2024; P2100803, Exp. Date 1/31/2024; P2101048, Exp. Date 1/31/2024; P2100794, Exp. Date 1/31/2024; P2100796, Exp. Date 1/31/2024; P2101403, Exp. Date 2/28/2024; P2101404, Exp. Date 2/28/2024; P2101819, Exp. Date 2/28/2024; P2101653, Exp. Date 2/29/2024; P2101654, Exp. Date 2/29/2024; P2101818, Exp. Date 2/29/2024; P2101820, Exp. Date 2/29/2024; P2102022, Exp. Date 3/31/2024; P2102023, Exp. Date 3/31/2024; P2102024, Exp. Date 3/31/2024; P2102025, Exp. Date 3/31/2024; P2102026, Exp. Date 3/31/2024; P2102096, Exp. Date 3/31/2024; P2102097, Exp. Date 3/31/2024; P2102098, Exp. Date 3/31/2024; P2102145, Exp. Date 3/31/2024; P2102293, Exp. Date 3/31/2024; P2102294, Exp. Date 3/31/2024; P2102295, Exp. Date 3/31/2024; P2103218, Exp. Date 3/31/2024; P2102296, Exp. Date 3/31/2024; P2103063, Exp. Date 5/31/2024; P2103062, Exp. Date 5/31/2024; P2103064, Exp. Date 5/31/2024; P2103065, Exp. Date 5/31/2024; P2106836, Exp. Date 7/31/2024; P2106015, Exp. Date 8/31/2024; P2106017, Exp. Date 8/31/2024; P2106016, Exp. Date 8/31/2024; P2106020, Exp. Date 8/31/2024; P2106018, Exp. Date 8/31/2024; P2106019, Exp. Date 8/31/2024; P2106596, Exp. Date 9/30/2024; P2106597, Exp. Date 9/30/2024; P2106599, Exp. Date 9/30/2024; P2106598, Exp. Date 9/30/2024; P2106601, Exp. Date 9/30/2024; P2107420, Exp. Date 10/31/2024; P2107421, Exp. Date 10/31/2024; P2107423, Exp. Date 10/31/2024; P2107636, Exp. Date 11/30/2024; P2107635, Exp. Date 11/30/2024; P2107637, Exp. Date 11/30/2024; P2107638, Exp. Date 11/30/2024; P2107640, Exp. Date 11/30/2024; P2107641, Exp. Date 11/30/2024; P2107642, Exp. Date 11/30/2024; P2107756, Exp. Date 11/30/2024; P2107757, Exp. Date 11/30/2024; P2107840, Exp. Date 11/30/2024; P2107758, Exp. Date 11/30/2024; P2107841, Exp. Date 11/30/2024; P2107844, Exp. Date 11/30/2024; P2107843, Exp. Date 11/30/2024; P2107900, Exp. Date 11/30/2024; P2107902, Exp. Date 11/30/2024; P2107903, Exp. Date 11/30/2024; P2200313, Exp. Date 12/31/2024; P2200314, Exp. Date 12/31/2024; P2200823, Exp. Date 1/31/2025; P2200824, Exp. Date 1/31/2025; P2200825, Exp. Date 1/31/2025; P2201048, Exp. Date 1/31/2025; P2201049, Exp. Date 1/31/2025; P2201055, Exp. Date 1/31/2025; P2201051, Exp. Date 1/31/2025; P2201053, Exp. Date 1/31/2025; P2201494, Exp. Date 2/28/2025; P2201754, Exp. Date 2/28/2025; P2201755, Exp. Date 2/28/2025; P2202210, Exp. Date 2/28/2025; P2202235, Exp. Date 2/28/2025; P2201756, Exp. Date 2/28/2025; P2203018, Exp. Date 5/31/2025; P2203017, Exp. Date 5/31/2025; P2203015, Exp. Date 5/31/2025; P2203019, Exp. Date 5/31/2025; P2204008, Exp. Date 6/30/2025; P2204378, Exp. Date 6/30/2025; P2204010, Exp. Date 6/30/2025; P2204073, Exp. Date 6/30/2025;
More code info: —