Sedative Recall Designated Class I

Fresenius Kabi USA is recalling 13,525 bottles of dexmedetomidine injection after trace amounts of the anesthetic lidocaine were discovered in the product. According to the December 16, 2020, US Food and Drug Administration (FDA) Enforcement Report, the recall has been designated Class I. The classification warns use of the affected product could cause serious adverse health consequences or death. 

The recall affects dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg/mL), in 50-mL single-dose bottles (NDC 63323-671-05) from lot 6123925. The product was distributed throughout the United States. 

Fresenius Kabi USA initiated the recall November 17, 2020. The FDA issued the Class I designation December 8, 2020. 

Dexmedetomidine is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting or for sedation of non-intubated patients during surgical and other procedures.

—Jolynn Tumolo