FDA Warns of Possible Contamination of Sterile Products from Compounding Pharmacy - - BioPharm International

ADVERTISEMENT

FDA Warns of Possible Contamination of Sterile Products from Compounding Pharmacy


RELATED ARTICLES

More in GMPs/Validation

FDA has alerted healthcare professionals of possible contamination in calcium gluconate infusions produced by Specialty Compounding (Cedar Park, TX). The agency has received 15 adverse event reports by patients in two hospitals that received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9% for injection. The patients developed bacterial bloodstream infections caused by Rhodococcus equi, and it is believed that the infections arerelated to the infusions. Bacterial growth consistent with Rhodococcus equi was found in cultures taken from Specialty Compounding’s calcium gluconate.

FDA and the Centers for Disease Control and Prevention are working with Texas state officials to investigate the cause of the bacterial infections. FDA is asking healthcare professions to report adverse reactions to FDA’s MedWatch program.

Source: FDA.gov

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

NIH Launches Human Safety Study of Ebola Vaccine Candidate
August 29, 2014
Suppliers Seek to Boost Single-Use Technology
August 21, 2014
Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
August 20, 2014
FDA Warns about Fraudulent Ebola Treatments
August 15, 2014
USP Awards Analytical Research
August 15, 2014
Author Guidelines

Click here