Fosaprepitant for Injection 150 mg per vial — Class II drug recall D-0262-2024
Terminated recall by BE PHARMACEUTICALS AG, reported 2024-01-31, distributed nationwide. Lack of Sterility Assurance: Aseptic process simulation failure.
| Recall number | D-0262-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BE PHARMACEUTICALS AG, Zug, N/A, Switzerland |
| Recall initiated | 2024-01-10 |
| Classified | 2024-01-25 |
| Reported by FDA | 2024-01-31 |
| Terminated | 2025-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 22,176 vials |
| Reason classes | sterility |
| NDC | 71839-0104, 71839-0104-01 |
| Lot numbers | 13D012AA |
| Expiration dates | 2025-08-31 |
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.
Reason for recall
Lack of Sterility Assurance: Aseptic process simulation failure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0262-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.