Exela Pharma Sciences with X-Gen announced a voluntary recall of Ibuprofen Lysine Injection 20mg/2mL (10mg/mL) vials due to the presence of particulate matter.
Ibuprofen Lysine is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing 500-1500g who are no more than 32 weeks gestational age when standard medical management is ineffective.
Administering a product with particulate matter can potentially block blood vessels, trigger an immune reaction, and/or lead to microinfarcts which could be life-threatening.
The affected products have Lot# PLND1613, NDC 39822-1030-2 and an expiration date of 02/2018. It was packaged in 2mL single-dose vials in 3-count cartons. X-Gen is notifying distributors and customers and is arranging for return of all recalled products.
To date, neither Companies have received reports of adverse events related to this recall.
For more information call (888) 451-4231 or visit FDA.gov.