Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Levetiracetam in 0.54% Sodium Chloride Injection Recalled by AuroMedics Pharma LLC Due to Lack of Assurance of Sterility; confirmed customer report...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AuroMedics Pharma LLC directly.
Affected Products
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.
Quantity: 67300 bags
Why Was This Recalled?
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AuroMedics Pharma LLC
AuroMedics Pharma LLC has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report