Oregon Compounding Centers, Inc. dba Creative Compounds recalls GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville,
Recalled November 12, 2014 · FDA recall D-0192-2015 · Oregon Compounding Centers, Inc.
Hazard
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. · FDA Class II
Units
800 mL
Sold at
Oregon, Washington
Description
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.
Product
GENTAMICIN SULFATE, 100mg/1000mL, solution for irrigation, 400 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070
Manufacturer(s)
Oregon Compounding Centers, Inc. dba Creative Compounds
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →