Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured ...
FDA Recall #D-0294-2019 — Class II — December 10, 2018
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
Reason for Recall
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Recalling Firm
Dr. Reddy's Laboratories, Inc. — Princeton, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,404 (30 count blister packs)
Distribution
Product was distributed to 4 major distributors who distributed the product throughout the United States.
Code Information
Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated