FDAFDA · Food and drugs·Recall number D-1035-2018
Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.
Published August 15, 2018 · Recall initiated: August 1, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LEVOFLOXACIN
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Nationwide USA and Puerto Rico
- UPC
- 0336000047241
- Lot
- Lot#: A0A0954, A0A0958, A0A0970, Exp 09/19
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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