Drug 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
D-0294-2019
Product summary
- Event
- Event 81748
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,404 (30 count blister packs)
- Official record key
drug-enforcement:D-0294-2019
Official wording
Reason: Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Code information: Lot #: T700423, Exp 08/2019; T800310, Exp 03/2020
Distribution pattern: Product was distributed to 4 major distributors who distributed the product throughout the United States.
Derived failure modes
-
Potency or specification failure
Out-of-Specification