Reported May 9, 2018 · Terminated
Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 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 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only
- Distributed ByAuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 CLV160013, CLV160014 and CLV160015, exp Sept 2018 2 CLV160022, CLV160023, CLV160024, CLV160025, CLV160026, CLV160027, CLV160028, CLV160029, CLV160030 exp Oct 2018 3 CLV170002, Dec 2018 4 CLV170010, exp April 2019 5 CLV170027, CLV170028, CLV170029 and CLV170030 exp Oct 2019 - Amount recalled
- 188941 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.
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