Drug product
Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
D-289-2013
Product summary
- Event
- Event 64957
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-289-2013
Official wording
Reason: Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Code information: ALL Lots
Distribution pattern: CO, GA, MI, and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility