Oregon Compounding Centers, Inc. dba Creative Compounds recalls LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Co
Recalled November 12, 2014 · FDA recall D-0201-2015 · 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
49/5 mL bottles; 40/6 mL bottles; 30/7 ml bottles
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
LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper 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 →