FDA recall D-0120-2021

Product

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05

Reason for recall

Cross Contamination with other products: trace amounts of lidocaine

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2020-11-17

Report date

2020-12-16

Termination date

2022-09-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0120-2021