Drug Safety Alerts

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

12/16/2020

On December 16, 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 number 6123925 exp. 03/2022 manufactured by Fresenius Kabi. This recall was issued due to the possibility of cross contamination with 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 November 17, 2020 to the user-level. On the December 16, 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 a.m. to 5:00 p.m (CT). You may also contact the FDA toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.accessdata.fda.gov.