Drug product
OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
D-0208-2015
Product summary
- Event
- Event 69519
- Status
- Terminated
- Classification
- Class II
- Quantity
- 680 mL
- Official record key
drug-enforcement:D-0208-2015
Official wording
Reason: 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.
Code information: Lot #: 20140711@1, discard date: 1/7/2015; Lot #: 20140814@22, discard date: 2/10/2015; Lot #: 20140815@13, discard date: 2/11/2015.
Distribution pattern: Oregon, Washington
Derived failure modes
-
Sterility assurance
Lack of Sterility