Reported May 9, 2018 · Terminated
Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only,…
AuroMedics Pharma LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AuroMedics Pharma LLC · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only
- Distributed ByAuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47
- Lot codes and dates
Lot/Batch #'s: CLV160016CLV160017and CLV160018exp Sept 2018CLV160019exp Oct 2018CLV160020CLV160021and CLV160031exp Nov 2018CLV160032 and CLV170001exp 12/18CLV170008 and CLV170009exp April 2019CLV170020CLV170021 and CLV170022exp Oct 2019
- Amount recalled
- 261250 bags
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new AuroMedics Pharma LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.