Drug Safety Alerts

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL Class I Recall

9/02/2020

On September 2, 2020, the United States Food and Drug Administration (FDA) published a notice regarding a Class I recall of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 200 mcg/50 mL lot numbers 6121853 exp. 05/2021 and 6122207 exp. 06/2021 manufactured by Fresenius Kabi. This recall was issued due to the possibility of cross contamination. The product may contain trace amounts of lidocaine.

This could be a health hazard or safety risk to patients using product affected by this recall.

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

This recall was previously issued on July 23, 2020 to the user-level. On the September 2, 2020 Enforcement Report, the FDA identified this as a Class I recall.

CVS Caremark Response:

Please note: This product is not carried by CVS Caremark® Mail Service Pharmacy.

For more information about this recall, please contact Fresenius Kabi at 1-866-716- 2459, Monday through Friday, 8:00 am to 5:00 pm (CT). You may also contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.accessdata.fda.gov.