PRASUGREL HYDROCHLORIDE Recall D-0280-2025
Description: Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
PRASUGREL HYDROCHLORIDE Recall D-0280-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0280-2025 |
| Event ID | 96369 |
| Brand | PRASUGREL |
| Generic Name | PRASUGREL |
| Manufacturer | PRASUGREL |
| Original Package? | 1 |
| Active Substance | PRASUGREL HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | US Nationwide. |
| Quantity | N/A |
| Recall Reason | Failed Dissolution Specifications - low dissolution results |
| Drug Classification | Class II |
| Drug Code Info | 20250326 |
| Product NDC | 0378-5185 0378-5186 |
| Drug UPC | 0303785185932 |
| Recall Initiation Date | 20250225 |
| Report Date | 20250326 |
| Classification Date | 20250317 |
| Address | 1311 Pineview DrN/A Morgantown, WV 26505-3276 United States |
| Recalling Firm | MYLAN PHARMACEUTICALS INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | G89JQ59I13 |
| Drug Application Number | ANDA205927 |
| Structured Product Labeling (SPL ID) | 9e234352-49b7-46e3-bc59-acf63e0a7a14 |
| Structured Product Labeling (SPL Set ID) | 41a4e332-6725-4cb7-940a-8291cf56cfe4 |
| Similar To |