Exile Pharma Sciences and its marketer X-Gen Pharmaceuticals Inc. are recalling one lot of Ibuprofen Lysine Injection used to treat a rare heart defect in premature infants because material was found floating in some of the vials. If injected, the material has the potential to block blood vessels, provoke and immune response, and/or lead to micro infarcts (cell death or tissue necrosis), which could be life threatening. To date, neither Exela nor X-Gen have received reports of adverse events related to this recall.
The recall involves lot number PLND1613 of Ibuprofen Lysine Injection, 20mg/2mL (10 mg/mL), with the NDC 39822-1030-2 and the expiration date of 02/2018. The product is packaged in three 2 mL Single-Dose vials per carton, and was distributed nationwide to wholesalers and distributors for further distribution to hospitals and retail customers.
Ibuproen Lysine Injection is used to close a clinically significant heart defect called patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 grams, who are no more than 32 weeks gestational age when usual medical management is ineffective.
X-Gen is notifying its distributors and customers and arranging for the return of all recalled products. 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.