CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

Recall Number: D-0183-2015

Firm: Oregon Compounding Centers, Inc. dba Creative Compounds

Classification: Class II

Status: Terminated

Report Date: 20141112

Initiation Date: 20141006

Termination Date: 20150630

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.

CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070