July 22, 2020

Fresenius Kabi has issued a voluntary recall of two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200mcg/50mL (4mcg/mL), 50mL fill in a 50mL vial. Vials belonging to the lots may be cross contaminated with trace amounts of lidocaine.

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use to sedate non-intubated patients prior to and/or during surgical and other procedures. As of the date of the recall, the manufacturer has not received any reports of adverse events related to the product. However, if the cross-contaminated product were to be used in a patient who has a lidocaine allergy, it could cause life-threatening anaphylaxis.

Questions regarding the recall should be directed to Fresenius Kabi at 1-866-716-2459. Patients who have experienced problems that may be related to use of the recalled drug should contact their healthcare provider. Adverse events can also be reported to the U.S. FDA’s MedWatch program. Additional recall information can be found on the FDA’s website.

There is no member impact through Benecard Central Fill.

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