Teva has voluntarily recalled 1 lot of Idarubicin Hydrochloride Injection USP 5mg/5 mL vial, to the consumer level due to particulate matter found in 1 vial identified as silica and iron oxide.
The recalled lot of Idarubicin Hydrochloride Injection USP 5mg/5 mL vial includes NDC Number 0703-4154-11; Lot Number 31329657B; Expiration Date 08/2023. A total of 1565 vials were distributed nationwide from December 4, 2020 to August 18, 2021 to wholesalers under the label for Teva Pharmaceuticals USA, Inc.
Idarubicin Hydrochloride Injection is indicated in combination with other approved antileukemic drugs for the treatment of acute myeloid leukemia in adults.
Administration of an IV product containing particulate matter may cause local irritation, swelling, or infection, and may cause stroke and potentially death if the particulate matter reaches the blood vessels. According to the Company’s internal health assessment, “the likelihood of patient harm is remote or unlikely.” To date, the Company has not received reports of product quality complaints or adverse event reports related to the recall.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
For more information regarding this recall contact Teva Pharmaceuticals USA, Inc. at (888) 838-2872, Option 3 then Option 4, or by email at [email protected].
Teva issues voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5 mg/5 mL due to the presence of particulate matter. News release. US Food and Drug Administration. March 29, 2022. Accessed April 1, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-idarubicin-hydrochloride-injection-usp-5-mg5-ml-due