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Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.
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.
The recall was initiated due to an internal inspection that found particulate matter, identified to be silica and iron oxide, in one vial of the product. No other vials have been observed to contain the particulate matter. Teva has not received any complaints regarding product quality or adverse events.
According to the company, if an injectable product containing particulate matter is administered, local irritation or swelling may occur in response to the foreign material. If this particulate matter reaches the blood vessels, it could cause blockages in various organs such as the heart, lungs or brain which can cause stroke and even lead to death. Though the health hazard risk could be severe if particulate matter is administered, Teva’s internal health assessment determined that the likelihood of patient harm is remote or unlikely.
IDArubicin Hydrochloride Injection USP is indicated for the treatment of acute myeloid leukemia (AML) in adults in combination with other approved anti-leukemic drugs. Teva notified its customers of the recall on March 28, 2022 and requested the return of impacted product. The company will continue to regularly update all relevant stakeholders and regulatory authorities to resolve the situation.