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Recall Observatory FDA recall evidence

Drug product

Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51

D-0703-2018

March 27, 2018

Class II

Product summary

Firm
AuroMedics Pharma LLC
Event
Event 79772
Status
Terminated
Classification
Class II
Quantity
395150 bags
Official record key
drug-enforcement:D-0703-2018

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: CLZ160001, CLZ160002, CLZ160003, CLZ160004 exp July 2018; CLZ160005, CLZ160006, CLZ160008, CLZ160009, CLZ160010 and CLZ160012, exp August 2018; CLZ160013, CLZ160014, CLZ160015, CLZ160016, exp October 2018; CLZ160017, CLZ160018, CLZ160019, CLZ160021, CLZ160022, CLZ160023, exp November 2018; CLZ170001, CLZ170002, CLZ170003, CLZ170004, CLZ170005, CLZ170006, exp March 2019; CLZ170007, CLZ170008, CLZ170009, CLZ170010, exp May 2019; CLZ170011, CLZ170012, exp June 2019; CLZ170013, CLZ170014, CLZ170015, CLZ170016, exp, September 2019; CLZ170017, exp October 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