The Recall Desk

FDA (Drugs) recall action 64957

Axium Healthcare Pharmacy dba Balanced Solutions Compounding recalled 26 products on 2013-05-01

The FDA (Drugs) publishes a recall like this one as 26 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 26 pages.

Products
26
Announced
2013-05-01
Critical
0
Units
—

Why these products were 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.

Lack of Sterility Assurance

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

26–26 of 26

  • SevereFDA (Drugs)··2013-05-01

    Axium Healthcare Recalls DMSO Bladder Irrigation Solution Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling DMSO 50% Sterile Bladder Irrigation Solution because the company cannot ensure the product is sterile.

    Product
    DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Distribution
    4 states