Recalling firm
BE PHARMACEUTICALS AG
Product type
Drug
Status
Terminated
Report date
2024-01-31
Distribution
Nationwide in the USA
Firm state
N/A
Product quantity
22,176 Vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Lack of Sterility Assurance: Aseptic process simulation failure.
Product description
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.
Code / lot info
lot #13D012AA, Exp: 08/31/2025
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.