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Recall Observatory FDA recall evidence

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

August 01, 2018

Class III

Product summary

Firm
Baxter Healthcare Corporation
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

    reason.potency_specification_failure · v1.0.0

    Superpotent