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FDAMarch 27, 2018drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

auromedics pharmaauromedics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear