Levetiracetam in 0 recalled over sterility concerns

Recall date

March 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

AuroMedics Pharma LLC recalls Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distri…

Recall number

D-0707-2018

FDA classification

Class II

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

US Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47.