Drug 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.
D-1034-2018
Product summary
- Event
- Event 80653
- Status
- Terminated
- Classification
- Class III
- Quantity
- 191,256 bags
- Official record key
drug-enforcement:D-1034-2018
Official wording
Reason: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Code information: Lot #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent