FDA recall D-0193-2015

Product

GENTAMICIN SULFATE, 480mg/1000mL, solution for irrigation, 300 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-0193-2015