Drug recall D-0294-2019
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.
Lots and codes
Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 4,404 (30 count blister packs)
- Distribution
- Product was distributed to 4 major distributors who distributed the product throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 10, 2018
- Terminated
- June 25, 2020
Related products
- Clopidogrel bisulfate – drug information
- NDC 55111-671 Clopidogrel bisulfate · Clopidogrel Bisulfate 300 mg/1 · Dr.Reddy's Laboratories Limited