FDA-Drug2018-05-09Class II
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.
AuroMedics Pharma LLC
Hazard
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Sold states
US Nationwide
Affected count
67300 bags
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0707-2018Don't want to check this manually?
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