Ibuprofen Lysine Injection Recalled Due to Particulate Matter

FDA officials announced that Exela Pharma Sciences has voluntarily issued a nationwide recall of its ibuprofen lysine injection 20 mg/2 mL (10 mg/mL) vials. According to the release, some of the lot PLND1613 injection vials have been found to contain particulate matter.

Ibuprofen lysine injection is indicated to close clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks old gestational age when usual medical management is ineffective.

The recalled product is packaged in three 2 mL single-dose vials per carton, and bears the NDC 39822-1030-2. X-Gen Pharmaceuticals, the product’s marketer, is notifying distributors and customers to arrange for return of the recalled vials. Exela and X-Gen have not received any reports of adverse events related to the recall, but FDA officials caution that particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts.

The FDA urges health care providers to report adverse reactions or quality problems associated with the use of the recalled product to the FDA’s MedWatch Adverse Event Reporting program.

Reference

Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Ibuprofen Lysine Injection, 20 Mg/2 Ml (10 Mg/Ml) Due to Particulate Matter [company announcement]. FDA’s website. http://www.fda.gov/Safety/Recalls/ucm540769.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed Feb 10, 2017.