The Food and Drug Administration (FDA) announced today the recall of a common antibiotic due to mold contamination.
AuroMedics Pharma is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017.
The product was found to contain white particulate matter that has been identified as mold.
Linezolid injection is supplied as a ready-to-use sterile, clear colorless to slightly yellow color isotonic solution for intravenous infusion. Each 300 mL contains 600 mg of linezolid.
It is available in single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap.
Healthcare professionals patients and consumers who have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate.
Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment 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.
- Malaria treatment: Eli Lilly announces discontinuation of IV quinidine
- Malaria drug: GSK seeks FDA approval of single-dose tafenoquine to treat Plasmodium vivax malaria
- FDA approves CMV prevention drug, PREVYMIS, for adult stem cell transplant patients
- Smallpox drug: NDA submitted to FDA