FDA recall D-0155-2020

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 for recall

Failed Dissolution Specification: Low out of specification dissolution results.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-10-18

Report date

2019-11-06

Termination date

2020-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2020