# FDA recall D-0730-2021

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2021-07-29.

## 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

- **Recall number:** D-0730-2021
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0730-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0730-2021. Source: US FDA. Licensed CC0.

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