FDA recall D-1024-2013

Product

PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800.

Reason for recall

Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-09-06

Report date

2013-09-18

Termination date

2014-01-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1024-2013