Teva Pharmaceuticals is voluntarily recalling one batch of its leukemia drug after potentially deadly particles were found in one vial.
An internal inspection found that the company’s IDArubicin Hydrochloride Injection, packed in 5 mL single dose vials, contained particles of silica and iron oxide. According to Teva, if injected, these particles could cause swelling or irritation at the injection site. In a worst-case scenario, the particles could reach blood vessels and travel to various organs and block blood vessels in the heart, lungs or brain which can cause a stroke or lead to death.
Teva distributed 1,565 vials of the batch across the United States from Dec. 4, 2020 to Aug. 18, 2021. Customers were notified of the recall on March 28, Teva said, and given instructions for how to return the drug.
Particles were only found in one of the vials, Teva said. As of now, the company has not received any product complaints or notice of any adverse safety events. According to the Israel-based generics superstar, the chance of patient harm is unlikely, despite the recall.
The potentially contaminated lot of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial is the lot numbered 31329657, vial/carton NDC 0703-4154-1.
Teva isn’t the only company having to call back a few of its products due to packaging woes lately. In January, Mylan voluntarily pulled one batch of Semglee —100 units/ml, 3mL— a non-interchangeable insulin glargine injection, due to the potential for missing labels on some of the prefilled pens.