Reported Apr 5, 2017 · Terminated
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences…
Claris Lifesciences Inc.
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: Claris Lifesciences Inc · 1445 US Highway 130 · North Brunswick, NJ · 08902-3100
Is this the product you have?
Levofloxacin Injection in 5% Dextrose750 mg in 150 mL 5% DextroseRx only
- Manufactured forClaris Lifesciences Inc. North Brunswick NJ, 08902
- ByClaris Injectable Ltd. Gujarat, India, NDC 36000-048-24
- Lot codes and dates
Lot #: A060040Exp. Dec 2017
- Amount recalled
- 24,456 units (1019 cartons x 24 bags)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
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.
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