DOXORUBICIN HYDROCHLORIDE Recall D-0048-2024
Description: Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01
DOXORUBICIN HYDROCHLORIDE Recall D-0048-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0048-2024 |
| Event ID | 93201 |
| Brand | DOXIL |
| Generic Name | DOXORUBICIN HYDROCHLORIDE |
| Manufacturer | DOXORUBICIN HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | DOXORUBICIN HYDROCHLORIDE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 472 vials |
| Recall Reason | CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake. |
| Drug Classification | Class II |
| Drug Code Info | 20231025 |
| Product NDC | 0338-0063 0338-0067 |
| Recall Initiation Date | 20230824 |
| Report Date | 20231025 |
| Classification Date | 20231017 |
| Address | 1 Baxter Pkwy Deerfield, IL 60015-4625 United States |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 82F2G7BL4E |
| Drug Application Number | NDA050718 |
| Structured Product Labeling (SPL ID) | 4915523a-9314-41a6-8e48-540db0acf65a |
| Structured Product Labeling (SPL Set ID) | 1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce |
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