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Midazolam Injection 2 mg/2 mL Prefilled Syringe Mislabeling

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Fresenius Kabi USA is recalling midazolam injection 2 mg/2 mL prefilled syringes due to mislabeling concerns. This recall affects a single lot (6400048), which contains syringes of ondansetron injection 4 mg/2 mL, but is labeled as midazolam injection 2 mg/2 mL. If an individual misses a dose of midazolam, ineffective sedation or increased anxiety associated with a procedure may occur. If an individual receives a pre-operative dose of ondansetron, and then mistakenly receives an additional dose of ondansetron, serious adverse effects may occur, including cardiac arrhythmias and serotonin syndrome. No adverse events connected to this recall have been reported to Fresenius Kabi. 
Additional information:

  • MedWatch Safety Alert – November 03, 2017
    www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm583860.htm
  • Fresenius Kabi USA press release – November 03, 2017
    www.fda.gov/Safety/Recalls/ucm583799.htm