Recall: D-1215-2018

Class III - Minor Violations

Class IIIClassification

2018-09-25Initiated

TerminatedStatus

Baxter Healthcare CorporationFirm

Product

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.

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.