Recall: D-0155-2020

Class II - Potentially Harmful

Class IIClassification

2019-10-18Initiated

TerminatedStatus

Mylan Pharmaceuticals Inc.Firm

Product

Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93

Reason

Failed Dissolution Specification: Low out of specification dissolution results.

Distribution

Nationwide within the United States

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