Fresenius Kabi has issued a voluntary recall of Midazolam Injection 2mg/2mL (Lot# 6400048), packaged in a 2mL prefilled single-use glass syringe. The product, which is labeled as Midazolam Injection, instead contains syringes with and labeled as Ondansetron Injection 4mg/2mL.
Midazolam is indicated for sedation, anxiety, and for induction of general anesthesia. A missed dose may lead to ineffective sedation and related patient recall of a surgical or diagnostic procedure.
Ondansetron is approved for the prevention of nausea and vomiting associated with cancer chemotherapy and for prevention of postoperative nausea and vomiting. If the incorrect medication is given, a patient who may have received a pre-operative dose of ondansetron may inadvertently receive another dose.
At this time, no reports of adverse events related to this recall have been received by the Company.
Healthcare professionals are encouraged to report adverse event to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
For more information visit FDA.gov.