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Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured ...

FDA Recall #D-0283-2019 — Class II — November 7, 2018

Recall #D-0283-2019 Date: November 7, 2018 Classification: Class II Status: Terminated

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: Out-of-Specification results were 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

4,212 (30-count blister pack)

Distribution

U.S.A.nationwide

Code Information

Lot #: T600530, Exp 11/18

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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