# FDA recall D-1507-2020

> **Sanofi-Aventis U.S. LLC** · Class II · drug recall initiated 2020-08-10.

## Product

Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75

## Reason for recall

Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-1507-2020
- **Recalling firm:** Sanofi-Aventis U.S. LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2020-08-10
- **Report date:** 2020-08-26

- **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-1507-2020

## Citation

> AI Analytics. FDA recall D-1507-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1507-2020. Source: US FDA. Licensed CC0.

---

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