FDA recall D-0280-2025

MYLAN PHARMACEUTICALS INC · Class II · drug

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 for recall

Failed Dissolution Specifications - low dissolution results

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2025-02-25
Report date
2025-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0280-2025