FDAFDA · Food and drugs·Recall number D-0705-2018
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.
Published May 9, 2018 · Recall initiated: March 27, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LEVETIRACETAM
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- US Nationwide
- UPC
- 0355150248476
- Lot
- Lot/Batch #'s: CLV160016, CLV160017, and CLV160018, exp Sept 2018, CLV160019, exp Oct 2018, CLV160020, CLV160021, and CLV160031, exp Nov 2018; CLV160032 and CLV170001, exp 12/18; CLV170008 and CLV170009, exp April 2019, CLV170020, CLV170021 and CLV170022, exp Oct 2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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