Fresenius Kabi USA is recalling one lot of the injectable sedative Midazolam because the syringes contain the anti-nausea drug ondansetron. This labeling mix-up may cause a variety of adverse events, the company warns, though no injuries related to this issue have been reported to date.
Midazolam is used to sedate, treat anxiety, and for the induction of general anesthesia. The recalled lot is packaged in a 2 mL profiled single-use glass syringe and packaged in a blister with 24 blisters per carton. The affected lot is marked with the NDC 76045-001-20, the product code 766120, and the lot number 6400048. The expiration date is July 2018. Affected products were sent to distributors throughout the U.S. from May 2017 to Oct. 18, 2017.
Ondansetron is used to prevent nausea and vomiting associated with cancer chemotherapy treatments and for the prevention of postoperative nausea and/or vomiting.
A missed dose of midazolam may lead to ineffective sedation and/or anxiety in a patient being prepared for a surgical or diagnostic procedure. If a selection error occurs, a patient who may have received a pre-operative dose of ondansetron may inadvertently receive an additional dose of ondansetron.
“Dose-dependent serious cardiac arrhythmias may be observed with higher dosages of ondansetron in those patients with certain pre-existing cardiac conditions,” the recall notice states.
Patients may also be at risk for serotonin syndrome, which is associated with increased serotonergic activity in the central nervous system. This condition is generally associated with the concomitant use of certain drugs commonly used during surgery, such as fentanyl. Some cases of serotonin syndrome were fatal.
Any adverse events related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice