FDA Drug Class II — Moderate

GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070

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.

Products

GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070
Brand
Oregon Compounding Centers, Inc. dba Creative Compounds
UPC
Lot #: 20140722@5, discard date: 10/20/2014; Lot #: 20140723@45, discard date: 10/21/2014.

Units Affected

250 mL