Recall: D-0705-2018

Class II - Potentially Harmful

Class IIClassification

2018-03-27Initiated

TerminatedStatus

AuroMedics Pharma LLCFirm

Product

Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47.

Reason

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.