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

Recall Number: D-0155-2020

Firm: Mylan Pharmaceuticals Inc.

Classification: Class II

Status: Terminated

Report Date: 20191106

Initiation Date: 20191018

Termination Date: 20200410

Reason for Recall

Failed Dissolution Specification: Low out of specification dissolution results.

Product Description

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