Recall: D-0262-2024

Class II - Potentially Harmful

Class IIClassification

2024-01-10Initiated

TerminatedStatus

BE PHARMACEUTICALS AGFirm

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

Lack of Sterility Assurance: Aseptic process simulation failure.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.