FDA recall D-0394-2016

Western Drug · Class II · drug

Product

Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

Key facts

Status: Terminated
Initiation date: 2015-10-19
Report date: 2015-12-09
Termination date: 2016-10-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Springerville, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0394-2016