Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

LAKE ZURICH, Ill., July 22, 2020 - Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investigation indicates that this issue is limited to these two product lots. This recall is being performed to the user level.

To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy, however, could result in anaphylaxis, a potentially life-threatening condition.

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.

Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between June 3, 2019 and April 8, 2020, as well as a copy of the label: