AuroMedics Pharma LLC is recalling one lot of the antibacterial injection Linezolid after white particulate identified as mold was spotted in some of some bags of the solution. Use of a sterile injectable contaminated with mold could cause a variety of fatal infections. To date, AuroMedics Pharma has not received any reports of adverse events or identifiable safety concerns related to this recall.
The recall affects Linezolid Injection 600mg/300mL flexible bags with the NDC 55150-242-51 batch CLZ160007 and the expiration date of August 2018. The batch was distributed to wholesalers and hospitals nationwide from May 15 thorugh Aug. 14, 2017. Linezolid injection is supplied as a ready-to-use sterile, clear colorless to slightly yellow color isotonic solution for intravenous infusion.
Linezolid injection is an oxazolidinone-class antibacterial indicated for adults and children with one of 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.
AuroMedics Pharma has contacted hospitals and wholesalers about this recall and is arranging for return and replacement of all affected products. Consumers that have affected products should stop using them immediately and return it to the place of purchase. Any adverse events related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Communication