Drug product
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
D-0155-2020
Product summary
- Event
- Event 84039
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,272 bottles
- Official record key
drug-enforcement:D-0155-2020
Official wording
Reason: Failed Dissolution Specification: Low out of specification dissolution results.
Code information: Lot #: 3089793, Exp. Date September 2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
out of specification