Fresenius Kabi USA, LLC recalls Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047;
Recalled July 22, 2020 · FDA recall D-1391-2020 · Fresenius Kabi USA
Hazard
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial. · FDA Class III
Units
63,067 vials
Sold at
Nationwide within the United States
Description
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Product
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →