Specialty Compounding, LLC Recalls All Lots of Unexpired Sterile Products After Reports of Adverse Events

August 14, 2013

Food and Drug Administration (FDA) has announced a voluntary recall of all lots of unexpired sterile products produced by Specialty Compounding, LLC, in Cedar Park, TX. FDA received reports of 15 adverse events at two hospitals (Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area) potentially related to the use of these sterile products. Affected patients received an intravenous infusion of calcium gluconate supplied by the company.

Patients who were administered the injectable drug products are at risk of life-threatening infections. The recall applies to all unexpired sterile compounded products dispensed by the company since May 9, 2013, including all strengths and dosage forms. Recalled products were distributed directly to hospitals and physicians' offices in Texas, and to patients located nationwide (with the exception of North Carolina). Health care providers and patients should stop using all recalled products and return them to Specialty Compounding. To return a product or for additional help, users should contact the company at 512/219-0724, Monday through Friday, between 10 AM and 5 PM CDT.

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