Drug 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.
D-0262-2024
Product summary
- Event
- Event 93747
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,176 Vials
- Official record key
drug-enforcement:D-0262-2024
Official wording
Reason: Lack of Sterility Assurance: Aseptic process simulation failure.
Code information: lot #13D012AA, Exp: 08/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Sterility