FDA recall D-0262-2024

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.

Reason for recall

Lack of Sterility Assurance: Aseptic process simulation failure.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2024-01-10

Report date

2024-01-31

Termination date

2025-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Zug, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0262-2024