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Recall Observatory FDA recall evidence

Drug product

Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for: AuroMedics Pharma, LLC, NDC 55150-243-46.

D-0704-2018

March 27, 2018

Class II

Product summary

Firm
AuroMedics Pharma LLC
Event
Event 79772
Status
Terminated
Classification
Class II
Quantity
46824 bags
Official record key
drug-enforcement:D-0704-2018

Official wording

Reason: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

Code information: Lot/Batch #'s: CLF160002, CLF160004, CLF160005 exp May 2018; CLF160006, CLF160007 exp June 2018; CLF170027 exp July 2019; CLF170029 exp August 2019

Distribution pattern: US Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    mold found
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility