According to a news report posted on informnny.com, Teva Pharmaceuticals has voluntarily recalled their IDArubicin Hydrochloride Injection USP five milligram or five-milliliter vials in the United States. The United States Food and Drug Administration stated that the recall was administered when the particulate matter in one vial was discovered during an internal inspection. The particulate was identified as iron oxide and silica. 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/milliliter vial. IDArubicin Hydrochloride Injection USP is used with anti-leukemic drugs to treat acute myeloid leukemia.
The Food and Drug Administration also warned that the affected product could cause swelling and/or local irritation if injected into a patient. Should the particulate matter reach a blood vessel and block blood vessels in the lungs, heart, or brain, causing a stroke leading to death.
Teva Pharmaceuticals USA, Inc. has recalled 1,565 vials Nationwide manufactured from December 4, 2020, through August 18, 2021. The recall information is listed below.
Product: IDArubicin Hydrochloride Injection USP five milligram/milliliter vial
Expiration Date: 08/2023
Consumers, medical clinics, hospitals, and distributors are urged to return the affected medicine. Instructions on returning recalled products and receiving credit are provided in the recall letter issued by Teva.
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