Teva Pharmaceuticals Recalls Acute Myeloid Leukemia Drug Over Particulate Matter Contamination

Teva IDArubicin Hydrochloride Injection USP Recall Overview: 

• Who: Teva Pharmaceuticals voluntarily recalled one lot of its IDArubicin Hydrochloride Injection USP 5 mg/5 mL vials.
• Why: Teva recalled the acute myeloid leukemia drug after discovering one of its vials contained particulate matter. 
• Where: The recall is nationwide. 

Teva Pharmaceuticals has voluntarily recalled one lot of its IDArubicin Hydrochloride Injection USP 5 mg/5 mL vials over concerns they were contaminated with particulate matter. 

The recall of the acute myeloid leukemia drug was initiated after an internal investigation discovered one vial contained silica and iron oxide, according to a recall notice published by the U.S. Food and Drug Administration. 

Teva says that no other vials were found to contain any unexpected particulate matter and that it has received no “quality complaints or adverse event reports of this nature for the subject recall lot.” 

The affected product was packed in 5 mL single-dose vials and distributed nationwide between Dec. 4, 2020, and Aug. 18, 2021, according to the recall. 

Teva says it distributed 1,565 vials of the recalled IDArubicin Hydrochloride Injection USP to a total of four wholesale customers. 

Teva Says Exposure To Particulate Matter Can Cause Problems

Exposure to an injectable product that contains particulate matter can lead to irritation or swelling in the area of injection, according to the recall. 

If the particulate matter gets absorbed into the bloodstream, Teva warns it can lead to death or stroke by traveling to and blocking blood vessels in the lungs, heart or brain. 

Despite this, Teva says that, based on an “internal health assessment,” the risk that a patient would be harmed as a result of exposure to the recalled IDArubicin Hydrochloride Injection USP is “remote” and “unlikely.” 

Teva says it began notifying its customers about the recall March 28, at which time it asked for arrangements to be made to have the affected product returned. 

Consumers with questions about the recall or who want to report an adverse event or quality complaint can contact Teva by phone at 888-838-2872, by email or online. 

Teva says it will continue to “partner with, and regularly update, all relevant stakeholders, including regulatory authorities, to resolve this situation.

A separate recall involving an injectable drug was initiated earlier this month by Adamis Pharmaceutical Corp. after the company discovered certain lots of its SYMJEPI (epinephrine) injection syringes could become clogged.

Have you used or purchased Teva’s IDArubicin Hydrochloride Injection USP acute myeloid leukemia drug? Let us know in the comments!

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