Recall: D-0280-2025

Class II - Potentially Harmful

Class IIClassification

2025-02-25Initiated

OngoingStatus

MYLAN PHARMACEUTICALS INCFirm

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

Reason

Failed Dissolution Specifications - low dissolution results

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.