Teva Pharmaceuticals has initiated a recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial in the United States due to the possible presence of particulate matter, the U.S. Food and Drug Administration said.
IDArubicin Hydrochloride Injection USP in combination with other approved anti-leukemic drugs is indicated for the treatment of acute myeloid leukemia or AML in adults.
The affected product lot's expiry date is 08/2023. It is packed in 5 mL Single Dose Vials. Teva distributed 1,565 vials across the nation from 12-04-2020 through 08-18-2021 to 4 of its Wholesale customers under the label for Teva Pharmaceuticals USA, Inc.
The recall was initiated after an 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.
The administration of an injectable product that contains particulate matter may result in local irritation or swelling or infection in response to the foreign material. The particulate matter, if reaches the blood vessels, can travel to various organs and block blood vessels in the heart, lungs or brain that can cause stroke and even death.
Teva said its internal health assessment determined that the likelihood of patient harm is remote or unlikely.
However, the company has not received any product quality complaints or adverse event reports for the recalled lots, which were produced and sold in 2020 and 2021, to date.
Teva has not received any product quality complaints or adverse event reports related to the recalled products to date.
In similar incidents, Fresenius Kabi USA in early March called back seven lots of Sodium Acetate Injection, USP to the user level due to the presence of particulate matter.
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