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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