D-292-2013 Class II Terminated
FDA drug recall D-292-2013 was initiated by Axium Healthcare Pharmacy dba Balanced Solutions Compounding on April 17, 2013 and is designated Class II. Reason for recall: Lack of Sterility Assurance The recall status is terminated (terminated April 19, 2017). Affected quantity: 1 vial (10 mL).
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2013
- Initiation Date
- April 17, 2013
- Termination Date
- April 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 vial (10 mL)
Product Description
HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Reason for Recall
Lack of Sterility Assurance
Distribution Pattern
CO, GA, MI, and Puerto Rico
Code Information
ALL Lots