RecallWatchUSA

Home / Recalls / Drugs

Fresenius Kabi USA, LLC recalls Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, prese

Recalled September 2, 2020 · FDA recall D-1537-2020 · Fresenius Kabi USA

Hazard
Cross Contamination with other products: trace amounts of lidocaine · FDA Class I
Units
25,100 bottles
Sold at
U.S.A. Nationwide

Description

Cross Contamination with other products: trace amounts of lidocaine

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
Manufacturer(s)
Fresenius Kabi USA, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov