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Recall Observatory FDA recall evidence

Drug product

Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52

D-0709-2018

March 27, 2018

Class II

Product summary

Firm
AuroMedics Pharma LLC
Event
Event 79772
Status
Terminated
Classification
Class II
Quantity
308112 bags
Official record key
drug-enforcement:D-0709-2018

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: CLF160012, CLF160014 exp July 2018; CLF170007, CLF170008, CLF170009, CLF170010, CLF170011, CLF170012, CLF170013 exp February 2019; CLF170014, CLF170015, CLF170016 exp March 2019; CLF170017, CLF170018, CLF170019, exp April 2019; CLF170020, CLF170021, CLF170022 exp May 2019; CLF170035, CLF170036, CLF170037, CLF170038 exp August 2019; CLF170048, CLF170049, CLF170050, CLF170051, CLF170052 exp September 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