Drug product
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
D-0280-2025
Product summary
- Event
- Event 96369
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0280-2025
Official wording
Reason: Failed Dissolution Specifications - low dissolution results
Code information: Lot # 3211073, 3211074, 3211075, Exp 4/30/2026
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications