D-1035-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 15, 2018
- Initiation Date
- August 1, 2018
- Termination Date
- July 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106,320 bags
Product Description
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.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lot#: A0A0954, A0A0958, A0A0970, Exp 09/19