Class II Recall

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
Status
Ongoing
Lot
Lot #: 3225272, Exp. September 30, 2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.