FDA-Drug2021-08-25Class II

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

Teva Pharmaceuticals USA
Hazard

Lack of Assurance of Sterility

Sold states
Product was distributed Nationwide, including Puerto Rico.
Affected count
1,351 vials
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0730-2021

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