PlainRecalls
FDA Drug Moderate Class II Terminated

Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Reported: May 1, 2013 Initiated: April 17, 2013 #D-280-2013

Product Description

Comprehensive injection #4 - SS varied injectable 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.

Details

Units Affected
10 vials (30 mL each)
Distribution
CO, GA, MI, and Puerto Rico
Location
Lake Mary, FL

Frequently Asked Questions

What product was recalled?
Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746. Recalled by Axium Healthcare Pharmacy dba Balanced Solutions Compounding. Units affected: 10 vials (30 mL each).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 1, 2013. Severity: Moderate. Recall number: D-280-2013.