Reported Aug 15, 2018 · Terminated
Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag,…
Baxter Healthcare Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
Levofloxacin Injection in 5% Dextrose250 mg (5 mg/mL)250 mg in 50 mL 5% Dextrose50 mL Single Use Container bagRx only
- Manufactured forClaris Lifesciences Inc., North Brunswick, NJ 08902
- ByClaris Injectables Ltd., Gujarat, India, NDC 36000-046-24
- Lot codes and dates
Lot #: A061178A061183A061236Exp 09/18A0A0937Exp 08/19A0A1044A0A1048Exp 10/19
- Amount recalled
- 191,256 bags
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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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