Recall: D-1034-2018

Class III - Minor Violations

Class IIIClassification

2018-08-01Initiated

TerminatedStatus

Baxter Healthcare CorporationFirm

Product

Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.

Reason

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Distribution

Nationwide USA and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.