FDA recall D-0730-2021

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

Reason for recall

Lack of Assurance of Sterility

Distribution

Product was distributed Nationwide, including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2021-07-29

Report date

2021-08-25

Termination date

2024-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

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