January 12, 2018
Fresenius Kabi USA is recalling prefilled midazolam injection, USP, 2 mg/2 ml (NDC 76045-001-20) because packages actually contain syringes of ondansetron injection, USP, 4 mg/2 mL, according to the January 10, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The FDA designated the recall Class I on January 4, 2018. The classification warns use of the injection could cause serious health problems or death in patients.
Midazolam is a benzodiazepine used to sedate patients before surgery or another medical procedure. Ondansetron a selective 5-HT3 receptor antagonist used to prevent nausea and vomiting after surgery or caused by chemotherapy.
The recall spans 203136 syringes distributed across the United States from lot 6400048.
Fresenius Kabi voluntarily initiated the recall October 27, 2017.
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