FDA recall D-1537-2020

Product

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 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

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2020-07-22

Report date

2020-09-02

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-1537-2020