# FDA recall D-0765-2022

> **Teva Pharmaceuticals USA Inc** · Class I · drug recall initiated 2022-03-29.

## Product

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.

## Reason for recall

Presence of Particulate Matter: Product was found to contain silica and iron oxide

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0765-2022
- **Recalling firm:** Teva Pharmaceuticals USA Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-03-29
- **Report date:** 2022-04-20
- **Termination date:** 2023-06-20

- **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-0765-2022

## Citation

> AI Analytics. FDA recall D-0765-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0765-2022. Source: US FDA. Licensed CC0.

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