D-0155-2020 Class II Terminated
FDA drug recall D-0155-2020 was initiated by Mylan Pharmaceuticals Inc. on October 18, 2019 and is designated Class II. Reason for recall: Failed Dissolution Specification: Low out of specification dissolution results. The recall status is terminated (terminated April 10, 2020). Affected quantity: 4,272 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2019
- Initiation Date
- October 18, 2019
- Termination Date
- April 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,272 bottles
Product Description
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 3089793, Exp. Date September 2020