# FDA recall D-0020-2023

> **AuroMedics Pharma LLC** · Class II · drug recall initiated 2022-09-30.

## Product

Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)

## Reason for recall

Subpotent Drug: Out of specification for assay

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0020-2023
- **Recalling firm:** AuroMedics Pharma LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-09-30
- **Report date:** 2022-11-02
- **Termination date:** 2024-09-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0020-2023

## Citation

> AI Analytics. FDA recall D-0020-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-0020-2023. Source: US FDA. Licensed CC0.

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