FDA Drug Class II — Moderate

PROCAINE HCL (BUFF), 1%, injectable, 10 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

PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Brand
Oregon Compounding Centers, Inc. dba Creative Compounds
UPC
Lot #: 20140905@11/10, discard date: 12/4/2014

Units Affected

540 mL