AuroMedics Pharma announced a voluntary recall of 1 lot of Linezolid injection 600mg/300mL flexible bags at the hospital level after it was found to contain white particulate matter identified as mold.
The mold discovery was following a product complaint where the contents of 1 flexible bag from a batch was found to contain white particulate matter. As a result, the Company is recalling Batch CLZ160007, NDC 5150-242-51 with expiration date August 2018. It is supplied as a solution for intravenous infusion in single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The contaminated batch was distributed to wholesalers and/or hospitals nationwide from May 15 through August 14, 2017.
Linezolid, an oxazolidinone-class antibacterial, is approved to treat patients for the following infections caused by susceptible Gram-positive bacteria: nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, uncomplicated skin and skin structure infections, and vancomycin-resistant Enterococcus faecium infections.
Injection of a non-sterile product can cause fatal infections for a wide range of patients. AuroMedics Pharma has not received any adverse event reports or any identifiable safety concerns associated with this recall.
For more information call (866) 850-2876 or visit FDA.gov.