Drug recall D-1035-2018
Product
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.
Reason for recall
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Lots and codes
Lot#: A0A0954, A0A0958, A0A0970, Exp 09/19
Recall details
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
- Quantity
- 106,320 bags
- Distribution
- Nationwide USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 1, 2018
- Terminated
- July 16, 2020
Related products
- Levofloxacin – drug information
- NDC 36000-045 Levofloxacin · Levofloxacin 25 mg/mL · Baxter Healthcare Corporation