Recalls / Class II
Class IID-292-2013
Product
HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
- Affected lot / code info
- ALL Lots
Why it was recalled
Lack of Sterility Assurance
Recalling firm
- Firm
- Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 550 Technology Park Ste 1008, Lake Mary, Florida 32746-7131
Distribution
- Quantity
- 1 vial (10 mL)
- Distribution pattern
- CO, GA, MI, and Puerto Rico
Timeline
- Recall initiated
- 2013-04-17
- FDA classified
- 2013-04-23
- Posted by FDA
- 2013-05-01
- Terminated
- 2017-04-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-292-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.