FDA Drug recall D-0155-2020
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc
- FDA Drug
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc by Mylan Pharmaceuticals, citing failed Dissolution Specification: Low out of specification dissolution results.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0155-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-18 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
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
Failed Dissolution Specification: Low out of specification dissolution results.
Identifiers
| ndc | 0378-5185-93 |
|---|---|
| ndc | 0378-5186-93 |
| code_info | Lot #: 3089793, Exp. Date September 2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0155-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.