Sodium Tetradecyl Sulfate Injectable Balanced Solutions — Class II drug recall D-272-2013
Terminated recall by Axium Healthcare Pharmacy dba Balanced Solutions Compounding, reported 2013-05-01, distributed in CO, GA, MI, PR. Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compoundin
| Recall number | D-272-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Axium Healthcare Pharmacy dba Balanced Solutions Compounding, Lake Mary, FL, United States |
| Recall initiated | 2013-04-17 |
| Classified | 2013-04-23 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2017-04-19 |
| Distributed | CO, GA, MI, PR |
| Quantity | 286 vials |
| Reason classes | sterility |
Product
Sodium Tetradecyl Sulfate 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.