MedWatch - The FDA Safety Information and Adverse Event Reporting Program
AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy 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. For product pictures, NDC, product code and batch numbers click the " Read Recall" red button below. 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.
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 form, or submit by fax to 1-800-FDA-0178.