Friday, December 21, 2012

Mass. Firm Tied to Closed Pharmacy Issues Recall | Reduction

Posted by

Mass. Firm Tied to Closed Pharmacy Issues Recall

FDA Drug Shortages Briefing (3151)
FDA Drug Shortages Briefing (3151) by The U.S. Food and Drug Administration
License (according to Flickr): United States Government Work
Excerpt:

A company with the same founders as the specialty pharmacy linked to deadly meningitis outbreak said Wednesday that it's recalling all its products after federal inspectors said it must improve its sterility testing process. Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, said she could not be specific about the problem at Ameridose. She would only say: "We found there was not adequate assurance of sterility in their sterile products." Woodcock stressed the agency knows of no infections linked to the recalled products. In a statement, Westborough-based Ameridose said it issued the recall "out of an abundance of caution." "Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death," the company said.

People:

Dr. Janet Woodcock

Overall Sentiment: -0.187356

Relevance: 0.943032

Barry Cadden

Overall Sentiment: -0.269247

Relevance: 0.605163

Stephen Runge

Overall Sentiment: 0.0670072

Relevance: 0.484885

SentimentQuote
0.0549486"Their marketing material is baloney. They are just saying what they want to say," said Stephen Runge, ...
Sentiment Stats:
  • Number of Quotes: 1
  • Aggregate Sentiment: 0.0549486
  • Mean: 0.0549486
  • Standard Deviation: 1.4142135623731

Greg Conigliaro

Overall Sentiment: 0

Relevance: 0.412002

Key:

  • Aggregate Sentiment is meant to be an indicator of an individual's overall sentiment.
  • The Mean is meant to be an indicator of an individual's average comment sentiment.
  • The Standard Deviation, when there are enough quotes, will indicate an individual's consistency of sentiment (i.e. a Standard Deviation of 0 would mean they were very consistent in their sentiment and 1 would mean they were very inconsistent).

Note that quote stats are likely to be meaningless beyond the aggregate score due to the tiny sample size. However, they are always provided just in case you find something useful there.

Additional Info:

PrintMedia: The Boston Globe

Overall Sentiment: 0.0118451

Relevance: 0.577879

Disambiguation: AwardPresentingOrganization | AwardWinner | Company | NewspaperReferences:

HealthCondition: meningitis

Overall Sentiment: -0.666327

Relevance: 0.71315

Organization: U.S. Food and Drug Administration

Overall Sentiment: 0.158236

Relevance: 0.964425

Organization: Center for Drug Evaluation and Research

Overall Sentiment: 0

Relevance: 0.523234

Organization: FDA

Overall Sentiment: 0

Relevance: 0.503827

Company: nanoCLEAN Decontamination Services

Overall Sentiment: 0.0273224

Relevance: 0.494606

Site Tags
at
Labels: , , , ,

No comments:

Post a Comment

Subscribe to: Post Comments (Atom)