# FDA recall D-0706-2018

> **AuroMedics Pharma LLC** · Class II · drug recall initiated 2018-03-27.

## Product

Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47.

## Reason for recall

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-0706-2018
- **Recalling firm:** AuroMedics Pharma LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-03-27
- **Report date:** 2018-05-09
- **Termination date:** 2022-02-18

- **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-0706-2018

## Citation

> AI Analytics. FDA recall D-0706-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0706-2018. Source: US FDA. Licensed CC0.

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