FDA-Drug2024-01-31Class II
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.
BE PHARMACEUTICALS AG
Hazard
Lack of Sterility Assurance: Aseptic process simulation failure.
Sold states
Nationwide in the USA
Affected count
22,176 Vials
Manufactured in
Bundesstrasse 3, N/A, Zug, N/A, Switzerland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0262-2024Don't want to check this manually?
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