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
Product summary
- 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
Labeling Error: Label Error