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Drug Recalls Due to Sterility Concerns

As confirmed by the U.S. Food and Drug Administration, in September alone five manufactures issued nationwide recalls for lots of pharmaceuticals due to sterility concerns.

Very often drug recalls are due to sterility concerns meaning that the manufacturer cannot ensure that the drug is free from contaminants such as bacteria or viruses which can put patients at risk of serious infections which may be life threatening. For instance Leiter’s Compounding Pharmacy recalled several lots of Bevacizumab, which is used to treat several types of cancers. Avella Specialty Pharmacy also recalled Bevacizumab. University Compounding Pharmacy recalled lots from the following three drugs, Testosterone Cyplonate, PG E-1 NS; and Testosterone CYP. Park Compounding Pharmacy also recalled Testosterone Cyplonate. Medaus Pharmacy recalled a whopping ten products because the sterility could not be confirmed.

Understanding Medication Recalls
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by the Food and Drug Administration request, or by FDA order under statutory authority. The FDA uses three levels to classify the severity of a drug recall. Class I recalls are where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recalls involve a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 
 Finally, Class III recalls are where the use of or exposure to a violative product is not likely to cause adverse health consequences. 


According to the FDA, many of the September recalls were Class I meaning consumers are at risk for serious adverse health consequences or death if the products are consumed. As consumers, we seek out medications and medical products to help cure or alleviate our ailments. Unfortunately, despite the best efforts of the FDA, consumers are all too often exposed to medications that can contain harmful bacteria or viruses and can cause major harm or even death if they are consumed. For instance, according to the Institute for Safe Medication Practices, in 2012 200 patients nationwide contracted fungal meningitis after receiving a steroid injection that had been contaminated.

Attorneys Who Can Help
These types of cases involving product liability as a result of a recalled pharmaceutical drug are often extremely complex and may require experienced legal counsel. Our Illinois injury lawyers at Levin & Perconti have skillfully handled a wide variety of product liability cases including those that touch on medical issues, like these medication recalls.

If you or a loved one has sustained harm or even death as a direct result of defective pharmaceuticals, please contact our attorneys for a free consultation to see what legal rights may be available to you.

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