Drug product
ASCORBIC ACID (with Preservative), 500 mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
D-0176-2015
Product summary
- Event
- Event 69519
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7900 mL
- Official record key
drug-enforcement:D-0176-2015
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 #: 20140827@34, discard date: 10/26/2014; Lot #: 20140909@22, discard dae: 11/8/2014; Lot #: 20140912@2, discard date: 11/11/2014.
Distribution pattern: Oregon, Washington
Derived failure modes
-
Sterility assurance
Lack of Sterility