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-0283-2019
Product summary
- Event
- Event 81530
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,212 (30-count blister pack)
- Official record key
drug-enforcement:D-0283-2019
Official wording
Reason: Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Code information: Lot #: T600530, Exp 11/18
Distribution pattern: U.S.A.nationwide
Derived failure modes
-
Potency or specification failure
Out-of-Specification