Prasugrel Tablets 5 mg — Class II drug recall D-0155-2020
Terminated recall by Mylan Pharmaceuticals Inc., reported 2019-11-06, distributed nationwide. Failed Dissolution Specification: Low out of specification dissolution results.
| Recall number | D-0155-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2019-10-18 |
| Classified | 2019-10-28 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2020-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 4,272 bottles |
| Reason classes | specification failure |
| NDC | 00378-5185, 00378-5185-93, 00378-5186, 00378-5186-93 |
| Lot numbers | 3089793 |
| Expiration dates | 2020-09-20 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0155-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.