Recall: D-0337-2018

Class I - Dangerous

Class IClassification

2017-12-20Initiated

TerminatedStatus

AuroMedics Pharma LLCFirm

Product

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

Reason

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

Distribution

Product was distributed throughout United States.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.