Recall
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
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.

View original FDA notice →

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