Drug & medication recalls Moderate risk

BE PHARMACEUTICALS AG recalls Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution a…

Recall date
January 10, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0262-2024
FDA classification
Class II
Brand / firm
BE PHARMACEUTICALS AG
Sold / distributed
Nationwide in the USA

Why it was recalled

Lack of Sterility Assurance: Aseptic process simulation failure.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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