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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