FDAClass IINovember 28, 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: Out-of-Specification results were 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 #: T600530, Exp 11/18

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
4,212 (30-count blister pack)
Distribution
U.S.A.nationwide
Recall date
November 28, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls