Product Description Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Recall Number D-289-2013

Classification Class II

Code Info ALL Lots

Product Distributed Qty

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.

Event Detail
Event Id 64957

Product Type Drugs

Status Ongoing

Recalling Firm Axium Healthcare Pharmacy dba Balanced Solutions Compounding
City Lake Mary
State FL

Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-04-17

Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern CO, GA, MI, and Puerto Rico