FDA Alerts Health Care Professionals about Sterile Products from Specialty Compounding
The U.S. Food and Drug Administration is alerting health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX, because bacterial infections have been potentially associated with contaminated calcium gluconate infusions produced by the company.
Calcium gluconate by infusion can be used to treat conditions associated with low calcium levels in certain circumstances.
- completing and submitting the report online at www.fda.gov/medwatch/report.htm; or
- downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.