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Recall: Midazolam Syringes in Blister Packs Contain Syringes of Ondansetron

Fresenius Kabi USA is recalling a lot of mislabeled prefilled syringes that were distributed nationwide.

Published: November 10, 2017

DRUG RECALL Your Zofran (ondansetron) syringes may be in blister packs labeled Versed (midazolam).

If your Versed isn't sedating patients, maybe it's because you're administering Zofran. Fresenius Kabi USA is recalling a lot of prefilled syringes that contain the antiemetic Zofran (ondansetron) but that are packaged in blister packs labeled as Versed (midazolam).

The syringes themselves are labeled correctly as Ondansetron Injection, USP, 4 mg/2 mL, but the blister packs are labeled Midazolam Injection, USP, 2 mg/2 mL, according to the recall.

The lot (6400048), which was divided into cartons that were also correctly labeled, was distributed to wholesale distributors nationwide between May 12, 2017 and October 18, 2017. It expires in July 2018.

A patient mistakenly given ondansetron instead of the sedative midazolam may be more aware during surgical and diagnostic procedures.

At the same time, if a patient with a cardiac condition is given a pre-op dose of ondansetron (to help prevent PONV) and then an inadvertent second dose, serious cardiac arrhythmias can occur. Patients given 2 doses of ondansetron may also be at risk for serotonin syndrome — a condition associated with increased serotonergic activity in the central nervous system. The condition usually involves concomitant use of other drugs used during surgery, including fentanyl, and it can be fatal.

Symptoms of serotonin syndrome include high temperature, agitation, increased reflexes, tremor, sweating, dilated pupils, and diarrhea. Severe cases can be characterized by seizures, irregular heartbeat and unconsciousness.

Fresenius Kabi USA, which is notifying distributors and customers, says it hasn't received any reports of adverse events related to the recall.

Healthcare professionals are encouraged to report related adverse events or side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program or to call 1-800-332-1088 and request a reporting form.

Jim Burger


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