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 for recall: Lack of Sterility Assurance: Aseptic process simulation failure.
Recall initiated: 20240110
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated