Tag Archives: drug recalls

What is a Recall?

About 4,500 drugs and devices are recalled yearly in the United States.  Prior to these recalls, they were approved by the FDA, widely injected, implanted and ingested by customers.  The FDA does not initiate a recall, they simply express concern and leave it up to the manufacture to execute a recall.  The FDA can only…
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Parenterals, Particulates, and Quality by Design

Particulate matter in parenteral drugs has been a known issue for over two centuries.  Particular matter could come from any little thing that is involved in the process of making the drug product.  Contaminants could come from the environment, packaging for the product, ingredients in the product, reactions of the formula and anything that could…
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Avoiding Glass Delamination

Cleanroon Technology published an article in 2011 titled Avoiding Glass Delamination. Delamination is where a material fractures into layers; it is a mode of failure and is unsafe in many scenarios. Delamination of a glass container carrying parenteral drugs has resulted in many drug recalls. This leads to particles in the drug itself; such as…
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Getting Particular About Particulates

Trisha Gladd, Editor for Life Science Connect, wrote an article for Pharmaceutical Online. Which talked about the rise of FDA recalls due to the presence of particulate matter in injectables. Trisha interviewed vice president of quality assurance at West Pharmaceutical Services, Bob Nase, who stated that the process of creating and filling the injectable drugs…
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