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FDA ISSUES RECALL NOTICE ABOUT MYLAN INJECTABLE PRODUCTS

FDA ISSUES RECALL NOTICE ABOUT MYLAN INJECTABLE PRODUCTS

The FDA recently warned healthcare professionals of a recall of various injectable medications by Mylan N.V. These pharmaceuticals include gemcitabine, carboplatin, methotrexate, and cytarabine, which are mostly used to treat various types of cancer. Mylan has recalled certain lots of these injectable products that were distributed in 2014. The reason for the nationwide recall is "the presence of visible foreign particulate matter observed during [sample] testing." Injection of pharmaceuticals containing such "foreign particulates has the potential of severe health consequences", including "life threatening adverse event[s]", "arterial emboli... result[ing] in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function or tissue necrosis."

As part of the voluntary recall, Mylan has sent a letter with safety instructions to its distributors and customers.

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm444517.htm

http://www.fda.gov/Safety/Recalls/ucm444498.htm

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