January 2024 FDA Recall Fosaprepitant by Be Pharmaceuticals Ag
D-0262-2024 - Lack of Sterility Assurance

This Class II drug recall was voluntarily initiated by Be Pharmaceuticals Ag on January 10, 2024 for the product Fosaprepitant. The FDA reported the reason for recall as lack of sterility assurance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0262-2024

Reason for Recall
Lack of Sterility Assurance: Aseptic process simulation failure.
Initiated
01-10-2024
Reported
01-31-2024
Quantity
22,176 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93747
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
BE PHARMACEUTICALS AG
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-10-2025
Product Description About Product Description
Full technical description of the product.
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

71839-104-01 Fosaprepitant