Tag Archives: Parenteral Final Products

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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Essentially Free:  How A Definition Tamed The Visible Particulate Matter Debate

In an article written by Louis Garguilo, Chief Editor for Outsourced Pharma, it talks about defining the term “essentially free” of visible particulate matter.  In 2005, it has become a big concern with the number of injectable drug product batches being rejected or recalled because of particulate matter being present. In 2014, recalls in injectable…
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