FDAHealthFebruary 25, 2025
MYLAN PHARMACEUTICALS INC — 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
⚠️ Failed Dissolution Specifications - low dissolution results
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 25, 2025
US Nationwide.
What's affected?
- Product
- 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
- Brand
- PRASUGREL
- UPC
- 0303785185932
- Lot code
- 3211073
Additional details
Lot # 3211073, 3211074, 3211075, Exp 4/30/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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