FDA recall D-0192-2015

Oregon Compounding Centers, Inc. dba Creative Compounds · Class II · drug

Product

GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Distribution

Oregon, Washington

Key facts

Status: Terminated
Initiation date: 2014-10-06
Report date: 2014-11-12
Termination date: 2015-06-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wilsonville, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0192-2015