Fosaprepitant Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 71839-104
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 71839-104). A significant event, classified as Class II, was initiated on Jan 10, 2024 by Be Pharmaceuticals Inc.. The reported reason for this action was: "Lack of Sterility Assurance: Aseptic process simulation failure."
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 II Terminated
Lack of Sterility Assurance: Aseptic process simulation failure.
Jan 10, 2024
Jan 31, 2024
22,176 Vials
Recall Profile & Regulatory Data
Event ID
93747
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
BE PHARMACEUTICALS AG
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jun 10, 2025
Product Description
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.
Batch or Lot Expiration Information
Lot# 13D012AA, Exp: 08/31/2025
Affected Packages Involved in this Recall
71839-104-01Product
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.
