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

Lundbeck CEO Resigns Due to Code of Conduct Breach
November 24, 2014
IMS: Global Spending on Medicines to Rise 30% by 2018
November 24, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Author Guidelines

Click here