July 2020 FDA Recall Fosaprepitant by Fresenius Kabi Usa, Llc
D-1391-2020 - Labeling Error
This Class III drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on July 13, 2020 for the product Fosaprepitant. The FDA reported the reason for recall as labeling error. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1391-2020
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.
07-13-2020
07-22-2020
63,067 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
08-19-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# : 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022
