Exela Pharma Sciences Recalls Ibuprofen Lysine Injection

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The company is voluntarily recalling product due to particulate matter.

On Feb. 8, 2017, Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, announced it was voluntarily recalling one lot of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) because of particulate matter found in some vials. The affected product, which was distributed nationwide to wholesalers and distributors, is from lot PLND1613 and has an expiration date of February 2018. The product has a X-Gen logo, and the NDC number on the individual vial is 39822-1030-1. As of February 8, the company had not received any reports of adverse events related to the recall.

According to Exela, Ibuprofen Lysine Injection is used to “close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective.” The company advises that particulate matter may block blood vessels, provoke an immune reaction, and/or lead to microinfarcts that could be life threatening.

The company recommends users stop use of the product and return the recalled lot to their distributor. Adverse events can be reported to FDA at www.fda.gov/medwatch/report.htm.


Source: FDA