Drug recall D-0155-2020
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
Reason for recall
Failed Dissolution Specification: Low out of specification dissolution results.
Lots and codes
Lot #: 3089793, Exp. Date September 2020
Recall details
- Recalling firm
- Mylan Pharmaceuticals Inc., Morgantown, WV
- Quantity
- 4,272 bottles
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 18, 2019
- Terminated
- April 10, 2020
Related products
- Prasugrel – drug information
- NDC 0378-5186 Prasugrel · Prasugrel Hydrochloride 10 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-5185 Prasugrel · Prasugrel Hydrochloride 5 mg/1 · Mylan Pharmaceuticals Inc.