# FDA recall D-0056-2018

> **Sanofi-Aventis U.S. LLC** · Class III · drug recall initiated 2017-10-13.

## Product

Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: Teva Pharmachemle, Swensweg 5, Haarlem, The Netherlands; Mfd for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; NDC 0955-1746-01.

## Reason for recall

Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0056-2018
- **Recalling firm:** Sanofi-Aventis U.S. LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-10-13
- **Report date:** 2017-11-08
- **Termination date:** 2020-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0056-2018

## Citation

> AI Analytics. FDA recall D-0056-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0056-2018. Source: US FDA. Licensed CC0.

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