Home / Recalls / BE PHARMACEUTICALS AG / D-0262-2024

D-0262-2024 Class II Terminated

Recalled by BE PHARMACEUTICALS AG — Zug, N/A

Recall Details

Product Type: Drugs
Report Date: January 31, 2024
Initiation Date: January 10, 2024
Termination Date: June 10, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22,176 Vials

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.

Distribution Pattern

Nationwide in the USA

Code Information

lot #13D012AA, Exp: 08/31/2025