D-0280-2025 Class II Ongoing
FDA drug recall D-0280-2025 was initiated by MYLAN PHARMACEUTICALS INC on Feb 25, 2025 and is designated Class II. Reason for recall: Failed Dissolution Specifications - low dissolution results The recall status is ongoing.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 26, 2025
- Initiation Date
- Feb 25, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
Product 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
Reason for recall
Failed Dissolution Specifications - low dissolution results
Distribution pattern
US Nationwide.
Code information
Lot # 3211073, 3211074, 3211075, Exp 4/30/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0280-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026