Recall: D-0294-2019

Class II - Potentially Harmful

Class IIClassification

2018-12-10Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

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 - 532 409, India, NDC 55111-671-31

Reason

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

Distribution

Product was distributed to 4 major distributors who distributed the product throughout the United States.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.