FDA Drug recall D-1103-2023
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deer…
- FDA Drug
- Class III
- completed
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class III recall of Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deer… by Baxter Healthcare, citing labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1103-2023 |
| Classification | Class III |
| Status | completed |
| Initiated | 2023-08-14 |
| Published | 2023-08-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
Reason
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Identifiers
| ndc | 10019-079-01 |
|---|---|
| code_info | Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1103-2023%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.