FDA Drug recall D-0262-2024
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single…
- FDA Drug
- Class II
- terminated
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single… by Be Pharmaceuticals Ag, citing lack of Sterility Assurance: Aseptic process simulation failure.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0262-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-01-10 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Be Pharmaceuticals Ag |
| Distribution | US |
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
Lack of Sterility Assurance: Aseptic process simulation failure.
Identifiers
| ndc | 71839-104-01 |
|---|---|
| code_info | lot #13D012AA, Exp: 08/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0262-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.