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.
Classification
Class II
Status
Terminated
Lot
lot #13D012AA, Exp: 08/31/2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
BE PHARMACEUTICALS AG — Class II Recall | MedicineWatch US