# FDA recall D-0270-2021

> **Areva Pharmaceuticals Inc** · Class II · drug recall initiated 2020-11-19.

## Product

Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva Pharmaceuticals, Inc., Gerogetown, IN 47122, Made in India, NDC 59923-714-02.

## Reason for recall

CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0270-2021
- **Recalling firm:** Areva Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-11-19
- **Report date:** 2021-03-03
- **Termination date:** 2022-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Georgetown, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0270-2021

## Citation

> AI Analytics. FDA recall D-0270-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/D-0270-2021. Source: US FDA. Licensed CC0.

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