Recalls / Class II
Class IID-0262-2024
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.
- Brand name
- Fosaprepitant
- Generic name
- Fosaprepitant
- Active ingredient
- Fosaprepitant Dimeglumine
- Route
- Intravenous
- NDC
- 71839-104
- FDA application
- ANDA212309
- Affected lot / code info
- lot #13D012AA, Exp: 08/31/2025
Why it was recalled
Lack of Sterility Assurance: Aseptic process simulation failure.
Recalling firm
- Firm
- BE PHARMACEUTICALS AG
- Manufacturer
- BE Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Bundesstrasse 3, N/A, Zug, N/A N/A, Switzerland
Distribution
- Quantity
- 22,176 Vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-01-10
- FDA classified
- 2024-01-25
- Posted by FDA
- 2024-01-31
- Terminated
- 2025-06-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0262-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.