FDA MedWatch - Injectable Products by Mylan: Recall - Presence of Particulate Matter - UPDATE

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Title: FDA MedWatch - Injectable Products by Mylan: Recall - Presence of Particulate Matter - UPDATE
MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

 

Injectable Products by Mylan: Recall - Presence of Particulate Matter

UPDATED 06/08/2015. Mylan is expanding its voluntary nationwide recall to the hospital/user level of select lots of Gemcitabine for Injection and Methotrexate Injection products due to the presence of visible foreign particulate matter observed during testing of retention samples. See the 06/08/2015 Press Release for product NDC and Lot numbers affected by this update.  Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. 

Read the entire MedWatch Alert at:

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


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