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GLMS received the following information from the Louisville Metro Department of Public Health & Wellness and wants our members to be aware of this important recall.
Dear Health Care Professionals and Regional Epidemiologists,
We do not know if this product was distributed in Kentucky, but please be aware of the situation detailed below and distribute to your clinicians as soon as possible.
Health Care Providers: If you have any sterile products from Specialty Compounding in Cedar Park, Texas, please stop using them and report any adverse health events potentially associated with these products per the instructions below.
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.
FDA has received reports of 15 adverse events experienced by patients in two hospitals. The 15 patients received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9% for Injection, which was supplied by Specialty Compounding. The patients then developed bacterial bloodstream infections caused by Rhodococcus equi. These infections are thought to be related to the infusions. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species.
Calcium gluconate by infusion can be used to treat conditions associated with low calcium levels in certain circumstances.
FDA is working closely with the Centers for Disease Control and Prevention (CDC) and the Texas state officials to investigate the cause of these bacterial infections. Health care professionals should report any adverse reactions to FDA's MedWatch program either by:
Thank you for your vigilance in this matter!
Doug Thoroughman, PhD, MS
CAPT, US Public Health Service
CDC Career Epidemiology Field Officer
Kentucky Department for Public Health
275 E. Main St., HS 2GW-C
Frankfort, KY 40621
Phone: 502-564-3418 x4315
Fax: 502-564-9626
douglas.thoroughman@ky.gov
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