Drug 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.
D-1035-2018
Product summary
- Event
- Event 80653
- Status
- Terminated
- Classification
- Class III
- Quantity
- 106,320 bags
- Official record key
drug-enforcement:D-1035-2018
Official wording
Reason: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Code information: Lot#: A0A0954, A0A0958, A0A0970, Exp 09/19
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent