BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Clinical Specialties Recalls Eye Drugs in Another Sterility Scare


3/21/2013 8:09:10 AM

Sterility problems persist at compounding pharmacies six months after the fungal meningitis outbreak, with yet another safety alert issued this week. The latest contamination is the result of a cost-saving measure — similar to one that resulted in the death of an East Nashville man last summer. After five people suffered eye infections, Clinical Specialties of Augusta, Ga., on Monday recalled shipments of Avastin injections that it had remixed into smaller doses. Three days earlier, Med Prep Consulting Inc. of Tinton Falls, N.J., suspended operations after fungal particles were observed floating in one of its IV medications. Although the U.S. Food and Drug Administration has increased inspections of pharmacies that remix brand-name medications or make non-patented drugs, agency officials say they need clearer authority. The two most recent recalls occurred after medical providers — not the FDA — spotted problems. Federal and state officials are still mulling over how to better regulate compounding pharmacies. The outbreak stemming from steroid medicine made by New England Compounding Center has sickened more than 700 people. Fifty have died. “We need the FDA to step in,” said Michael Cohen, president of the Institute for Safe Medication Practices. “If we don’t have an infrastructure that we can trust, and we can’t get essential drugs we need from traditional manufacturers, patients are always going to be at risk.” Med Prep Consulting has recalled all of its products as a precaution. The drug with the floating particles, magnesium sulfate, was shipped to New Jersey, Pennsylvania, Connecticut and Delaware. “Magnesium sulfate is an essential product for magnesium replacement, prevention of seizures in pregnant women with pre-eclampsia and has other uses,” Cohen said. “If people can’t get it from traditional manufacturers, they either have to make it themselves or get it from a compounder. In this case, hospitals around the country needed it.”

Read at tennessean.com
Read at CBS News
Read at Washington Post
Read at News Release
Read at Wall Street Journal

 
 

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES