Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only ...
FDA Recall #D-0262-2024 — Class II — January 10, 2024
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.
Reason for Recall
Lack of Sterility Assurance: Aseptic process simulation failure.
Recalling Firm
BE PHARMACEUTICALS AG — Zug, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
22,176 Vials
Distribution
Nationwide in the USA
Code Information
lot #13D012AA, Exp: 08/31/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated