# FDA recall D-0804-2018

> **Sanofi-Aventis U.S. LLC** · Class II · drug recall initiated 2018-04-27.

## Product

Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01

## Reason for recall

Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.

## Distribution

US nationwide

## Key facts

- **Recall number:** D-0804-2018
- **Recalling firm:** Sanofi-Aventis U.S. LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-27
- **Report date:** 2018-05-09
- **Termination date:** 2021-01-20

- **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-0804-2018

## Citation

> AI Analytics. FDA recall D-0804-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0804-2018. Source: US FDA. Licensed CC0.

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