23 Nov

ISSUE: Fresenius Kabi is recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level.

To date, no adverse drug experience reports have been received for the recalled lot.

The administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction.

BACKGROUND: Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

RECOMMENDATION: Fresenius Kabi is notifying distributors and customers to:

• Check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.

•  Patients should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Source: USFDA

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