Exela Pharma Sciences, LLC voluntarily recalled a lot of its ibuprofen lysine injection vials after discovering some of the vials contained particulate matter.
The FDA announced the recall in a news release on Feb. 8.
Ibuprofen lysine injection is used to close a clinically significant patent ductus arteriosus in premature infants when medical management is ineffective.
Exela and marketer X-Gen Pharmaceuticals have received no adverse event reports related to the recall. However, the companies said that participate matter could block blood vessels, provoke an immune reaction and/or lead to potentially life threatening microinfarcts.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.