DAUNOrubicin Hydrochloride Injection Recalled Due to Sterility Assurance
Teva Pharmaceuticals USA is recalling DAUNOrubicin Hydrochloride Injection 20 mg/4mL due to lack of assurance of sterility. The recall affects 1,351 vials distributed nationwide, including Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall, and sterility assurance failure in injectable drugs poses a serious risk of infection. Although no illnesses are reported in the source text, the hazard directly affects sterile drug administration and meets the Class II threshold for severity.
Plain-English summary
Teva Pharmaceuticals USA is recalling DAUNOrubicin Hydrochloride Injection 20 mg/4mL single-dose vials (NDC# 0703-5233-11 and carton NDC# 0703-5233-13) due to lack of assurance of sterility. The affected product is Lot #31329250B with an expiration date of 08/2022.
A total of 1,351 vials have been distributed nationwide, including Puerto Rico. This is a prescription-only medication manufactured by Teva Parenteral Medicines, Inc. in Irvine, CA.
Patients and healthcare providers who have received or dispensed this product should not use it. Consult your healthcare provider for guidance on obtaining a replacement or alternative treatment. If you have questions about this recall, contact Teva Pharmaceuticals USA.
The recalled product
- Product
- DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable / Oncology
- Affected units
- 1,351
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 31329250B
- exp. date 08/2022
Distribution
Part of a larger recall action
This product is one of 19 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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