Fosaprepitant Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 63323-972
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fosaprepitant (NDC 63323-972). A significant event, classified as Class III, was initiated on Jul 13, 2020 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
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.
Jul 13, 2020
Jul 22, 2020
63,067 vials
Recall Profile & Regulatory Data
Event ID
86018
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Aug 19, 2022
Product Description
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
Affected Packages Involved in this Recall
63323-972-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
