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
Recall Number: D-0280-2025
Firm: MYLAN PHARMACEUTICALS INC
Classification: Class II
Status: Ongoing
Report Date: 20250326
Initiation Date: 20250225
Termination Date:
Reason for Recall
Failed Dissolution Specifications - low dissolution results
Product Description
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