Drug recall D-1034-2018
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 for recall
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Lots and codes
Lot #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19
Recall details
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
- Quantity
- 191,256 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