FDA Drug Class II — Moderate

ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, 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

ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
Brand
Oregon Compounding Centers, Inc. dba Creative Compounds
UPC
Lot #: 20140902@17/1.25; discard date: 10/17/2014

Units Affected

5 mL