# FDA recall D-0153-2018

> **Sanofi-Aventis U.S. LLC** · Class III · drug recall initiated 2017-12-05.

## Product

Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10

## Reason for recall

Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL

## Distribution

Distributed nationwide.

## Key facts

- **Recall number:** D-0153-2018
- **Recalling firm:** Sanofi-Aventis U.S. LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-05
- **Report date:** 2018-01-17
- **Termination date:** 2019-10-11

- **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-0153-2018

## Citation

> AI Analytics. FDA recall D-0153-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0153-2018. Source: US FDA. Licensed CC0.

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