FDA recall D-276-2013

Product

Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium 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-276-2013