Recall: D-0703-2018
Class II - Potentially Harmful
Class IIClassification
2018-03-27Initiated
TerminatedStatus
AuroMedics Pharma LLCFirm
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
Reason
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Distribution
US Nationwide
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.