D-0155-2020 Class II Terminated
FDA drug recall D-0155-2020 was initiated by Mylan Pharmaceuticals Inc. on Oct 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 Apr 10, 2020). Affected quantity: 4,272 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 6, 2019
- Initiation Date
- Oct 18, 2019
- Termination Date
- Apr 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0155-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026