# FDA recall D-0075-2018

> **Genzyme Corporation** · Class III · drug recall initiated 2017-10-12.

## Product

Clolar (clofarabine) 20 mg/20 mL (1 mg/mL)  Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5   Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.

## Reason for recall

Labeling: Incorrect or Missing Package Insert.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0075-2018
- **Recalling firm:** Genzyme Corporation
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-10-12
- **Report date:** 2017-11-22
- **Termination date:** 2020-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0075-2018

## Citation

> AI Analytics. FDA recall D-0075-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0075-2018. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
