Drug product
HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
D-292-2013
Product summary
- Event
- Event 64957
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 vial (10 mL)
- Official record key
drug-enforcement:D-292-2013
Official wording
Reason: Lack of Sterility Assurance
Code information: ALL Lots
Distribution pattern: CO, GA, MI, and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Sterility