Teva recalls IDArubicin Hydrochloride Injection 5mL vials due to silica and iron oxide particles. This may cause serious complications if injected. Contact Teva for details.
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Teva is recalling IDArubic: 5mL single-dose vials of IDArubicin Hydrochloride Injection for intravenous use. The product contains silica and iron oxide particles that could cause serious complications if injected.
The injection contains silica and iron oxide particles that could cause serious complications when administered intravenously. These particles may lead to blockages or other adverse reactions in the bloodstream.
Healthcare professionals who use this medication for intravenous treatment. Patients receiving this drug under a prescription are at risk if they receive the recalled vials.
Check for the 5mL single-dose vials labeled 'IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use'. The product was manufactured by Teva Pharmaceuticals USA, Inc. in North Wales, PA with lot number 31329657B and expires 08/2023.
Identify the vial by checking the label for 'IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use' and lot number 31329657B.
The recall indicates the product contains silica and iron oxide particles that could cause serious complications if injected. Teva has not provided a specific remedy, so it is not safe to use.
The recall record does not specify a remedy. You should contact Teva Pharmaceuticals USA, Inc. for further instructions.
Check the vial label for the product name, lot number 31329657B, and expiration date 08/2023.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0765-2022 — Teva Teva Hello, I own a Teva that is covered by recall D-0765-2022 from Teva. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.