FDA recall D-0337-2018

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 for recall

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

Distribution

Product was distributed throughout United States.

Key facts

Status

Terminated

Initiation date

2017-12-20

Report date

2018-02-14

Termination date

2019-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0337-2018