Teva recalls one lot of IDArubicin Hydrochloride Injection USP

Lot 31329657B of Teva’s IDArubicin Hydrochloride Injection USP 5mg/5ml vials is being recalled across the US due to particulates.

Teva logo on sign outside facility in Whitchurch-Stouffville, On, Canada [Credit: JHVEPhoto/].

[Credit: JHVEPhoto/].

Teva is voluntarily recalling lot 31329657B of IDArubicin Hydrochloride Injection USP 5mg/5ml vial, to the user level in the US. The nationwide recall was initiated after an internal internal inspection 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 and, 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-leukaemic drugs, is indicated for the treatment of acute myeloid leukaemia (AML) in adults.

Information on the affected product is below:

IDArubicin Hydrochloride Injection USP 5mg/5ml vial

Vial/Carton NDC: 0703-4154-11

Lot Number: 31329657B

Expiry Date: 08/2023

Teva distributed 1,565 5ml single dose vials nationwide between 4 December 2020 and 18 August 2021 to 4 wholesaler customers. The company notified its customers of the recall on 28 March 2022, asking them to make arrangements for impacted product to be returned. Instructions for returning recalled product and crediting are given in the recall letter released by Teva.

This recall was made with the knowledge of the US Food and Drug Administration (FDA). Teva will continue to partner with, and regularly update, all relevant stakeholders, including regulatory authorities, to resolve this situation.