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

FDA recall notice · announced December 19, 2018 · Dr. Reddy's Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

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

Notes

Distribution: Product was distributed to 4 major distributors who distributed the product throughout the United States.
Lot/code information: Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020
Quantity: 4,404 (30 count blister packs)
Status: Terminated
Products in this recall event:
- 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 (D-0294-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.