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Recall Observatory FDA recall evidence

Drug 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

D-1391-2020

July 13, 2020

Class III

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 86018
Status
Terminated
Classification
Class III
Quantity
63,067 vials
Official record key
drug-enforcement:D-1391-2020

Official wording

Reason: 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.

Code information: Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling Error: Label Error