FDAFDA · Food and drugs·Recall number D-0208-2015
OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Published November 12, 2014 · Recall initiated: October 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Oregon Compounding Centers, Inc. dba Creative Compounds
- Distributor
- Oregon, Washington
- Lot
- Lot #: 20140711@1, discard date: 1/7/2015; Lot #: 20140814@22, discard date: 2/10/2015; Lot #: 20140815@13, discard date: 2/11/2015.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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