Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic inf...
FDA Recall #D-0337-2018 — Class I — December 20, 2017
Product Description
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 for Recall
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Recalling Firm
AuroMedics Pharma LLC — East Windsor, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
9,050 bags
Distribution
Product was distributed throughout United States.
Code Information
Lot # CLZ160007, Exp August 2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated