FDAFDA · Food and drugs·Recall number D-0707-2018
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.
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: CLV160004, CLV160005, and CLV160006 exp September 2018; CLV170011, CLV170015, CLV170016 exp June 2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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