Drug product
CITRIC ACID/GLUCONOLACTONE MAGNES CARB (RENACIDIN), 66/1.98/31.77 mg/mL, solution for irrigation, 30 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070
D-0183-2015
Product summary
- Event
- Event 69519
- Status
- Terminated
- Classification
- Class II
- Quantity
- 900 mL
- Official record key
drug-enforcement:D-0183-2015
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 #: 20140908@2, discard date: 10/23/2014
Distribution pattern: Oregon, Washington
Derived failure modes
-
Sterility assurance
Lack of Sterility