Last Updated on December 31, 2023 by The Health Master
Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial, to the user level in the United States.
This voluntary recall is initiated based on an internal inspection that found particulate matter in one vial of the product identified as silica and iron oxide.
No other vials have been observed to contain this defect. To date, Teva has received no product quality complaints or adverse event reports of this nature for the subject recall lot.
The administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material.
If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death.
While the health hazard risk could be severe if particulate matter is infused, Teva’s internal health assessment determined that the likelihood of patient harm is remote or unlikely
IDArubicin Hydrochloride Injection USP in combination with other approved anti-leukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults.
Information about the affected product is listed in the table below. It is packed in 5 mL Single Dose Vials. Teva distributed 1,565 vials Nationwide from 12-04-2020 through 08-18-2021 to 4 of its Wholesale customers under the label for Teva Pharmaceuticals USA, Inc.
| Vial/Carton NDC | Lot # | Exp. Date |
|---|---|---|
| 0703-4154-11 | 31329657B | 08/2023 |
This recall was made with the knowledge of the Food and Drug Administration. Teva will continue to partner with, and regularly update, all relevant stakeholders, including regulatory authorities, to resolve this situation.
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