Class II Recall

Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-cou

Summary

The FDA issued a Class II for Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 167 by Accord Healthcare, Inc.. Reason: CGMP Deviations: recalling drug products following an FDA inspection..

Details

Source

Drug Recall

External ID

D-0392-2023

Action Date

2023-03-08

Status

Terminated

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

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, 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;

Quantity Affected: 2,731,365 bottles

Reason for Recall

CGMP Deviations: recalling drug products following an FDA inspection.

Distribution

United States including Puerto Rico and Canada

Type: Voluntary: Firm initiated

Recall Initiated: 2023-02-07

Company

Accord Healthcare, Inc.

Durham, NC

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 123 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.

Accord Healthcare, Inc. has 90 FDA actions in our database, including 90 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Accord Healthcare, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Accord Healthcare, Inc. have FDA actions?

Accord Healthcare, Inc. has 90 FDA actions in our database, including 90 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "D-0392-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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