Navigation Links
'Greenish-Black' Contaminant in Vials of Steroid Behind Meningitis Outbreak: FDA
Date:10/28/2012

By Steven Reinberg and Margaret Steele
HealthDay Reporters

FRIDAY, Oct. 26 (HealthDay News) -- Federal investigators who toured the plant at the center of the ongoing meningitis outbreak found foreign, "greenish-black" material in some vials of the injectable steroid suspected as the cause of the illnesses, U.S. health officials said Friday.

The contaminated product was one of a host of potential violations discovered during a recent inspection of the New England Compounding Center's plant in Framingham, Mass., officials said.

"The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside," Steven Lynn, director of the U.S. Food and Drug Administration's Office of Manufacturing and Product Quality, said during a news conference Friday afternoon.

As of Friday, the U.S. Centers for Disease Control and Prevention said that 25 people have now died and 338 people in 18 states have been sickened in the nationwide fungal meningitis outbreak.

Vials from the lot Lynn described were shipped by the company to customers this year, he said. The FDA tested 50 of these vials and all were contaminated with fungus, he added.

In addition, the company couldn't demonstrate that the equipment used to sterilize these products was actually able to sterilize them, Lynn said.

The FDA also found the company was not able to keep its "clean room" clean, Lynn said. "A clean room is a space designed to maintain a controlled environment with low levels of airborne particles and surface contamination," he explained.

According to the report, the company failed to keep the air conditioner in the clean room running at night, which is standard practice to maintain the room's humidity and temperature control. In the past, the company itself had found mold and b
'/>"/>

Copyright©2012 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3 4

Related medicine news :

1. UGA researchers develop rapid diagnostic test for pathogens, contaminants
2. Reused Vials, Unsafe Injections Threatening Patients: CDC
3. Gatekeeper of brain steroid signals boosts emotional resilience to stress
4. Inhaled Steroids Lead to Big Drop in Asthma Deaths at Texas Hospital: Study
5. Steroid Nasal Sprays Show Small Benefit for Sinusitis: Study
6. Identifying asthma patients who tolerate lower doses of steroids remains problematic
7. Trivedi Beef, LLC Announces Breakthrough Beef Industry Data without the use of Antibiotic Drugs, Hormones or Steroids
8. Low steroid levels linked to increased risk of cardiovascular disease
9. Vitamin D deficiency and poorer lung function in asthmatic children treated with steroids
10. The scientific side of steroid use and abuse
11. Steroids Wont Ease Most Sinusitis Attacks, Study Finds
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
'Greenish-Black' Contaminant in Vials of Steroid Behind Meningitis Outbreak: FDA
(Date:9/17/2014)... 17, 2014 (HealthDay News) -- Present-day Europeans are ... ancient humans, according to a new study. ... indigenous hunter-gatherers and early European farmers. But, a ... they are also the descendants of Ancient North ... from this third ancestral group, researchers from Harvard ...
(Date:9/17/2014)... HealthDay Reporter WEDNESDAY, Sept. 17, 2014 ... explain why antibiotic-resistant bacteria can thrive in a hospital setting. ... be the culprit. They can easily enter bacteria and move ... that makes bacteria drug-resistant, a new study finds. "The ... a class of antibiotic called carbapenems," said the study,s co-author, ...
(Date:9/17/2014)... Mathematics might be able to reduce the need for ... the autoimmune disease lupus. , In a new study, ... progression from nephritis kidney inflammation to interstitial ... reverse. A kidney biopsy is the only existing way ... its extent. , The model could also be used ...
(Date:9/17/2014)... Today, Blue Shield of California Foundation ... This body of grants aims to support California’s safety ... delivery, as well as to develop new coverage and ... strengthen the capacity of both domestic violence and healthcare ... entry points for domestic violence screening and services. , ...
(Date:9/17/2014)... In a country where 77% of inhabitants suffer ... how can Americans find healthy and fulfilling ways to ... , a 5-day interactive journey to putting stress into ... September 29th – October 3rd, the Hyland’s Stress Challenge ... topics that promote natural solutions for managing stress. , ...
Breaking Medicine News(10 mins):Health News:Europeans Are Descendants of at Least 3 Ancient Human Groups: Study 2Health News:Europeans Are Descendants of at Least 3 Ancient Human Groups: Study 3Health News:Researchers Discover How Bacteria Resist Antibiotics in Hospitals 2Health News:Researchers Discover How Bacteria Resist Antibiotics in Hospitals 3Health News:Math model designed to replace invasive kidney biopsy for lupus patients 2Health News:Blue Shield of California Foundation Awards $5 Million in Third-Quarter Grants 2Health News:Stress Less with the Hyland's 5-Day Stress Challenge 2
... has increased its health budget by over 30 percent ... a new medical college//. ,"In a bid to ... medical education department budget to about Rs.1.52 billion. This ... billion," an official said. ,"The government not ...
... the June Journal of the American Society of Nephrology ... for chronic renal failure//. ,"Our results confirm an ... as an important causative factor in kidney disease," comments ... of the new study. ,Dr. Ejerblad and colleagues ...
... According to a new study by New York University School ... New York City are severely infected// with hepatitis B virus. ... the liver gets inflamed and can ultimately lead to cirrhosis ... 12 issue of Morbidity and Mortality Weekly, published by the ...
... new study, oral and intravenous antiviral drug may be ... ,Shingles, which is caused by varicella-zoster virus, is a ... at the University of Colorado and Health Sciences Center ... three women with moderate to severe pain following shingles. ...
... Middle school students have expressed a high degree of comfort ... schools are safer// , and make the students feel wanted. ... other schools. Psychologists from UCLA and UC ... than 70 sixth-grade classrooms in 11 Los Angeles public middle ...
... which is a severe form of food poisoning, now has ... team of researchers working at the University of Bristol//. ... researchers have narrowed down on a particular antibiotic called fosfomycin, ... effective in the laboratory, this drug has never been considered ...
Cached Medicine News:Health News:Kidney Failure three times pronounced with obesity 2Health News:Asian American Community Prone To Hepatitis B infection 2Health News:Asian American Community Prone To Hepatitis B infection 3Health News:Comfort Level, Maximum in Ethnically Diverse Schools 2Health News:Comfort Level, Maximum in Ethnically Diverse Schools 3
(Date:9/17/2014)... DALLAS , Sept. 17, 2014   OTEMR, ... 2014 Edition Complete EHR certification, which designates that the ... the Stage 1 and Stage 2 Meaningful Use measures ... and Reinvestment Act (ARRA).  ONETOUCH EMR 2.0 was certified ... an Office of the National Coordinator-Authorized Certification Body (ONC-ACB) ...
(Date:9/17/2014)... -- Bayer HealthCare will present data on hemophilia A research ... Meeting, which takes place September 18-20 in ... shared through poster presentations, showcase Bayer,s commitment to advancing ... presented in a scientific forum. "With posters ... patients, Bayer is maintaining its commitment to research in ...
(Date:9/17/2014)... 2014  Lightbeam Health Solutions announced today an ... Direct ACO) to deploy the Lightbeam population health ... care while reducing costs. Photo - ... Accountable Care Organization is the ACO operating entity ... mission is to be the premier integrated health ...
Breaking Medicine Technology:OTEMR, Inc.'s ONETOUCH EMR Achieves ONC HIT 2014 Edition COMPLETE EHR Certification from ICSA Labs 2OTEMR, Inc.'s ONETOUCH EMR Achieves ONC HIT 2014 Edition COMPLETE EHR Certification from ICSA Labs 3Bayer to Present Data on Hemophilia Research at NHF in Washington, D.C. 2Bayer to Present Data on Hemophilia Research at NHF in Washington, D.C. 3Bayer to Present Data on Hemophilia Research at NHF in Washington, D.C. 4Physician Direct Accountable Care Organization Selects Lightbeam Health to Enable Better Care at a Lower Cost 2Physician Direct Accountable Care Organization Selects Lightbeam Health to Enable Better Care at a Lower Cost 3
... AUSTIN, Texas, March 4, 2011 Vermillion, Inc. (Nasdaq: ... Gail Page, Vermillion,s Chief Executive Officer, will be presenting at ... Ritz Carlton, Laguna Niguel in Dana Point, CA. ... 1:00 p.m. Pacific. The presentation will be web cast and ...
... Halozyme Therapeutics, Inc. (Nasdaq: HALO ), ... extracellular matrix , today announced it plans to ... March 11, 2011 before the open of the financial ... call with the investment community at 8:00 a.m. PT ...
Cached Medicine Technology:Vermillion to Present at the Roth 23rd Annual OC Growth Stock Conference March 13-16, 2011, Laguna Niguel, CA 2Vermillion to Present at the Roth 23rd Annual OC Growth Stock Conference March 13-16, 2011, Laguna Niguel, CA 3Halozyme Therapeutics to Host Fourth Quarter and 2010 Financial Results Conference Call on March 11 2
... semi-dry electrophoretic transfer cell and PowerPac ... Efficient Transfers. Minimal Buffer Requirements. ... and Reliable Transfers. Single-Step Locking ... Capacity to Transfer Multiple Gels. ...
... Transfers depurinated DNA and RNA from agarose ... as 15 minutes ,Increases speed and efficiency ... be applied to gel ,Part of an ... and UV crosslinking in 2.5 hours, versus ...
PosiBlot 30-30 Sponges...
PosiBlot 30-30 Pads...
Medicine Products: