Tags: blood | infections | sterile | products | FDA | Texas | compounding

Blood Infections Prompt FDA Recall of Sterile Products

Monday, 12 Aug 2013 07:18 AM

The U.S. Food and Drug Administration said on Sunday that Specialty Compounding LLC will voluntary recall its full line of sterile products used to inject drugs, citing concerns about bacterial bloodstream infections.

The FDA said none of the company's products purchased after May 9 should be used and that they should be quarantined and returned to Specialty Compounding.
 
The company, which makes specialty products used to inject drugs that have been personalized for patients, first announced the recall on Friday. FDA spokesman Curtis Allen said the agency followed the company's statement with its own press release to publicize the recall more widely.
 
The products being recalled were distributed directly to patients in all 50 U.S. states, except for North Carolina, as well as to hospitals in Texas.
 
The FDA said 15 patients in Texas developed bacterial bloodstream infections after receiving calcium gluconate injections. Calcium gluconate typically helps patients that have low calcium levels.
 
"The FDA believes that use of these products would create an unacceptable risk for patients," said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.
 
Cedar Park, Texas-based Specialty Compounding was not immediately available to comment.

© 2017 Thomson/Reuters. All rights reserved.

 
1Like our page
2Share
Health-News
The U.S. Food and Drug Administration said on Sunday that Specialty Compounding LLC will voluntary recall its full line of sterile products used to inject drugs, citing concerns about bacterial bloodstream infections. The FDA said none of the company's products purchased...
blood,infections,sterile,products,FDA,Texas,compounding
192
2013-18-12
Monday, 12 Aug 2013 07:18 AM
Newsmax Inc.
 

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved