Teva Pharmaceuticals USA recalls DAUNOrubicin Hydrochloride Injection 20 mg/4mL vials due to lack of sterility assurance. This could lead to infections if used improperly.
Lack of Assurance of Sterility
Teva is recalling DAUNOrubicin Hydrochloride Injection 20 mg/4mL vials because they may not be sterile. This poses a risk of infection if the medication is used.
The vials may not be sterile, which could lead to infections if the medication is administered. This is a serious risk for patients undergoing chemotherapy.
Patients prescribed this chemotherapy medication by a doctor. Those using the product without medical supervision are at risk.
Check for vials labeled DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, with NDC# 0703-5233-11 and Carton NDC # 0703-5233-13. Lot number 31329250B, expiring 08/2022.
Verify the NDC numbers and lot number to confirm if your vials are affected.
The recall states there is a lack of assurance of sterility, so it is not safe to use without the remedy.
Check for vials labeled DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, with NDC# 0703-5233-11 and Carton NDC # 0703-5233-13, Lot number 31329250B, expiring 08/2022.
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0730-2021 — Teva Teva Hello, I own a Teva that is covered by recall D-0730-2021 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.