Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31

Recall Number: D-0283-2019

Firm: Dr. Reddy's Laboratories, Inc.

Classification: Class II

Status: Terminated

Report Date: 20181128

Initiation Date: 20181107

Termination Date: 20200519

Reason for Recall

Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.

Product Description

Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31