Friday, July 24, 2020

Recall Alert: FDA MedWatch Safety Alert: Dexmedetomidine Hydrochloride Injection by Fresenius Kabi

CVM is sharing this recall announcement because these products may be used in veterinary settings.

TOPIC: Dexmedetomidine Hydrochloride Injection by Fresenius Kabi: Recall - Due to Cross - Contamination of Lidocaine

AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy

ISSUE: Fresenius Kabi is 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 due to the possible presence of trace amounts of lidocaine in these two lots based on FDA investigation. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in anaphylaxis, a potentially life-threatening condition.

To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi.

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.

List of recalled lots and product photos below:
RECOMMENDATION: Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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