FDA-Drug2013-05-01Class II
Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Hazard
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.
Sold states
CO, GA, MI, and Puerto Rico
Affected count
286 vials (30 mL vials each)
Manufactured in
550 Technology Park Ste 1008, Lake Mary, FL, United States
Products
Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-272-2013Don't want to check this manually?
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