BE PHARMACEUTICALS AG: Drug Recall
Recall #D-0262-2024 · 01/10/2024
Class II: Risk
Recall Details
- Recall Number
- D-0262-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- BE PHARMACEUTICALS AG
- Status
- Terminated
- Date Initiated
- 01/10/2024
- Location
- Zug, N/A, Switzerland
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,176 Vials
Reason 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.
Distribution Pattern
Nationwide in the USA
Other Recalls by BE PHARMACEUTICALS AG
- Class II: Risk 09/05/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.