Class I Recall for Chemotherapy Drug

A voluntary recall of 1565 vials of idarubicin hydrochloride injection initiated by Teva Pharmaceuticals USA Inc has been designated Class I by the US Food and Drug Administration (FDA) Enforcement Report. The most serious recall classification, a Class I designation communicates that use of an affected product could cause significant adverse health consequences or death.

According to the April 20, 2022, FDA Enforcement Report, silica and iron oxide particulate matter were found in vials.

The recall affects idarubicin hydrochloride injection, 5 gm/5mL (1 mg/mL), 5-mL single-dose vials (NDC 0703-4154-11), from lot 31329657B (Exp. 8/23). The vials were distributed throughout the United States.

Teva Pharmaceuticals USA initiated the recall March 29, 2022. The FDA issued its Class I designation April 11, 2022.

Idarubicin hydrochloride injection in used in combination with other approved antileukemic drugs to treat adults with acute myeloid leukemia.