Recalls / Class II

Class IID-0409-2023

Product

Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle NDC 16729-004-17, UPC 3 16729 00417 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Brand name

Simvastatin

Generic name

Simvastatin

Active ingredient

Simvastatin

Route

Oral

NDCs

16729-004, 16729-005, 16729-006, 16729-007, 16729-156

FDA application

ANDA078155

Affected lot / code info

Batches: a) P2106923, Exp. Date 9/30/2023; R2101544, Exp. Date 10/31/2023; R2200732, Exp. Date 5/31/2025; b) P2101634, Exp. Date 2/28/2023; P2102370, Exp. Date 3/31/2023; P2102321, Exp. Date 3/31/2023; P2102411, Exp. Date 3/31/2023; P2102454, Exp. Date 3/31/2023; P2103991, Exp. Date 5/31/2023; R2100954, Exp. Date 6/30/2023; R2100947, Exp. Date 6/30/2023; R2100951, Exp. Date 6/30/2023; P2106242, Exp. Date 8/31/2023; P2106928, Exp. Date 9/30/2023; P2107424, Exp. Date 9/30/2023; R2101542, Exp. Date 10/31/2023; R2101543, Exp. Date 10/31/2023; R2200026, Exp. Date 11/30/2023; R2200414, Exp. Date 2/29/2024; R2200416, Exp. Date 2/28/2025; R2200586, Exp. Date 4/30/2025; R2200679, Exp. Date 5/31/2025; R2200824, Exp. Date 5/31/2025;

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection.

Recalling firm

Firm

Accord Healthcare, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446

Distribution

Quantity

291,378 bottles

Distribution pattern

United States including Puerto Rico and Canada

Timeline

Recall initiated

2023-02-07

FDA classified

2023-03-02

Posted by FDA

2023-03-08

Terminated

2024-04-22

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0409-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.