FDA-Drug2020-07-22Class III
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
Fresenius Kabi USA, LLC
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.
Sold states
Nationwide within the United States
Affected count
63,067 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1391-2020Don't want to check this manually?
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