Linezolid Injection 600 mg/ recalled over mold contamination

Recall date

December 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

AuroMedics Pharma LLC recalls Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil l…

Recall number

D-0337-2018

FDA classification

Class I

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

Product was distributed throughout United States.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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