FDA Alerts

Recall - midazolam injection

Recall - midazolam injection, 2 mg/2 mL by Fresenius Kabi - Packages contain syringes of ondansetron injection. Fresenius Kabi USA is voluntarily recalling lot 6400048 (expires July 2018) of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection, USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection, USP, 4 mg/2 mL.

A missed dose of midazolam may lead to ineffective sedation and/or anxiety related to patient recall of 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. Patients may also be at risk for serotonin syndrome. Serotonin syndrome is associated with increased serotonergic activity in the central nervous system. Most reports of serotonin syndrome have been associated with concomitant use of certain drugs, some commonly used during surgery, such as fentaNYL. Some of the reported cases of serotonin syndrome were fatal.

Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have the affected lot, they are to immediately discontinue distributing, dispensing or using the lot and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped, or may have been shipped the product involved in this recall.

Consumers with questions regarding this recall can contact Fresenius Kabi Quality Assurance at 1-866-716-2459. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.

More Alerts

On December 22, 2021, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for PAXLOVID, consisting of oral tablets of nirmatrelvir that are co-packaged with oral tablets of ritonavir (an FDA-approved antiretroviral agent). Indications Emergency use of Paxlovid is
Ever since the US Food and Drug Administration (FDA) authorized the emergency use of a specific formulation (10 mcg/0.2 mL) of the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine for children ages 5 through 11 years, reports of mix-ups with the Pfizer-BioNTech COVID-19 vaccine
Since the 2021-22 influenza (flu) vaccine became available last month, the Institute for Safe Medication Practices (ISMP) has received 16 cases of accidental influenza and coronavirus disease 2019 (COVID-19) vaccine mix-ups. All reports were sent by consumers or healthcare practitioners via one of