FDAClass IIDecember 19, 2018

Clopidogrel Tablets recall: Failed Dissolution

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…

Why was Clopidogrel Tablets recalled?

Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020

Product
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…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
4,404 (30 count blister packs)
Distribution
Product was distributed to 4 major distributors who distributed the product throughout the United States.
Recall date
December 19, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls