FDA recall D-292-2013

Axium Healthcare Pharmacy dba Balanced Solutions Compounding · Class II · 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

Reason for recall

Lack of Sterility Assurance

Distribution

CO, GA, MI, and Puerto Rico

Key facts

Status
Terminated
Initiation date
2013-04-17
Report date
2013-05-01
Termination date
2017-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Mary, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-292-2013