FDAFDA · Food and drugs·Recall number D-1034-2018
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.
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 #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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