(WWTI) — Teva Pharmaceuticals has issued a voluntary nationwide recall of their Hydrochloride Injection which was distributed across the United States.
According to the United States Food and Drug Administration, the recall was issued after an internal inspection that found particulate matter in one vial of the product identified as silica and iron oxide. Although the defect was not discovered among any of the other vials the company has recalled lot 31329657B of IDArubicin Hydrochloride Injection USP five milligram or five-milliliter vial.
IDArubicin Hydrochloride Injection USP in combination with other approved anti-leukemic drugs is used for the treatment of acute myeloid leukemia in adults.
The FDA warned that if the affected product is injected it could result in local irritation or swelling. Additionally, 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 lead to death.
Although the risk is severe, Teva’s internal health assessment determined that the likelihood of patient harm is unlikely. There have been no product quality complaints or reports of injury for the subject recall lot to date.
Teva reportedly 1,565 vials Nationwide from December 4 of 2020 through August 18 of 2021 to four of its wholesale customers under the label for Teva Pharmaceuticals USA, Inc. The specific recall information for the product is listed below.
|Vial/Carton NDC||Lot #||Exp. Date|
Those who have the recalled product are encouraged to make arrangements to return it. Instructions for returning recalled products and crediting are given in the recall letter released by Teva. More information can be found on the FDA website.