FDA Drug Class II — Moderate

METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 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

METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Brand
Oregon Compounding Centers, Inc. dba Creative Compounds
UPC
Lot #: 20140718@2/0.3, discard date: 1/14/2015; Lot #: 20140808@4/0.3, discard date: 2/4/2015; Lot #: 20140902@36/1, discard date: 3/1/2015; Lot #: 20140902@37/0.3, discard date: 3/1/2015; Lot #: 20140912@22/1, discard date: 3/11/2015.

Units Affected

119/0.3 mL vials and 106/1 mL vials