Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51

Recall Number: D-0337-2018

Firm: AuroMedics Pharma LLC

Classification: Class I

Status: Terminated

Report Date: 20180214

Initiation Date: 20171220

Termination Date: 20190624

Presence of Particulate Matter; white particulate matter identified as mold was found in one bag

Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51