D-0262-2024 Class II Terminated
FDA drug recall D-0262-2024 was initiated by BE PHARMACEUTICALS AG on January 10, 2024 and is designated Class II. Reason for recall: Lack of Sterility Assurance: Aseptic process simulation failure. The recall status is terminated (terminated June 10, 2025). Affected quantity: 22,176 Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- January 31, 2024
- Initiation Date
- January 10, 2024
- Termination Date
- June 10, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,176 Vials
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.
Reason for Recall
Lack of Sterility Assurance: Aseptic process simulation failure.
Distribution Pattern
Nationwide in the USA
Code Information
lot #13D012AA, Exp: 08/31/2025