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
- Recalling Firm
- Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- 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.
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