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Recall Observatory FDA recall evidence

Drug product

Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.

D-1036-2018

August 01, 2018

Class III

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 80653
Status
Terminated
Classification
Class III
Quantity
711,216 bags
Official record key
drug-enforcement:D-1036-2018

Official wording

Reason: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Code information: Lot #: A060940, A060948, A060951, A060956, A060958, A060963, Exp 07/18; A061105, A061110, A061113, A061115, A061119, Exp 08/18; A061243, Exp 09/18; A0A0813, Exp 07/19; A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925, Exp 08/19; A0A0971, A0A0976, Exp 09/19; A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, A0A1004, 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