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

FDA recall notice · announced July 22, 2020 · Fresenius Kabi

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

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.

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022
Quantity: 63,067 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.