Reported May 9, 2018 · Terminated
Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion,…
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?
- Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only
- Manufactured ByAurobindo Pharma Limited IDA Pashamylaram - 502307, India
- Manufactured forAuroMedics Pharma, LLC, NDC 55150-243-46
- Lot codes and dates
Lot/Batch #'s: CLF160002CLF160004CLF160005 exp May 2018CLF160006CLF160007 exp June 2018CLF170027 exp July 2019CLF170029 exp August 2019
- Amount recalled
- 46824 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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