Mylan Pharmaceuticals Inc: Prasugrel Tablets, Usp, 10mg
- Recalling firm
- Mylan Pharmaceuticals Inc
- Product
- Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
- Reason
- Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-17
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the U.S
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/fbae3b18-f8ec-4b0a-aabc-87e687033708