Fresenius Kabi USA is voluntarily recalling a single lot of dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg /mL), 50-mL fill in a 50-mL vial due to the presence of a trace amount of lidocaine. This recall is being performed to the user level with the knowledge of the FDA.
The recalled lot was distributed nationwide to wholesalers, distributors, hospitals and pharmacies from April 9 to April 13, 2020 (Table).
Dexmedetomidine hydrochloride in 0.9% sodium