Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Recall Number: D-0412-2023

Firm: Accord Healthcare, Inc.

Classification: Class II

Status: Terminated

Report Date: 20230308

Initiation Date: 20230207

Termination Date: 20240422

CGMP Deviations: recalling drug products following an FDA inspection.

Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA