Status
Ongoing
Drug Enforcement D-0280-2025
Failed Dissolution Specifications - low dissolution results
Classification
Class II
Report Date
March 26, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- N/A
- Reason for recall
- Failed Dissolution Specifications - low dissolution results
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide.
Location & Firm
- Recalling firm
- Mylan Pharmaceuticals Inc
- Address
-
1311 Pineview Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0280-2025
- Event ID
- 96369
- Recall initiation date
- February 25, 2025
- Center classification date
- March 17, 2025
- Code info
- Lot # 3211073, 3211074, 3211075, Exp 4/30/2026
- More code info
- —