D-284-2013 Class II Terminated
FDA drug recall D-284-2013 was initiated by Axium Healthcare Pharmacy Dba Balanced Solutions Compounding on Apr 17, 2013 and is designated Class II. 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… The recall status is terminated (terminated Apr 19, 2017). Affected quantity: 6 vials (5 mL and 10 mL each).
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2013
- Initiation Date
- Apr 17, 2013
- Termination Date
- Apr 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 vials (5 mL and 10 mL each)
Product Description
BiMix Plus 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 Pattern
CO, GA, MI, and Puerto Rico
Code Information
ALL Lots
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-284-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026