FDA recall D-277-2013

Axium Healthcare Pharmacy dba Balanced Solutions Compounding · Class II · drug

Product

Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Reason for recall

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.

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-277-2013