ADVERTISEMENT
News
Sedative Recall Designated Class I
12/17/2020
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