rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-235-01, UPC 3 16729 23501 3

Recall Number: D-0428-2023

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.

rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-235-01, UPC 3 16729 23501 3