FDA Drug Class II — Moderate

PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 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

PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Brand
Oregon Compounding Centers, Inc. dba Creative Compounds
UPC
Lot #: 20140910@48/1.25, discard date: 10/25/2014; Lot #: 20140911@11/1.25, discard date: 10/26/2014; Lot #: 20140916@17/1.25, discard date: 10/31/2014.

Units Affected

15 mL