MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramIbuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate MatterAUDIENCE: Pediatrics, Cardiology, Critical Care Medicine ISSUE: Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, Inc., is voluntarily recalling lot number PLND1613 of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL), vials to the hospital or user level. Some of the vials have been found to contain particulate matter. Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening. Neither Exela nor X-Gen has received any reports of adverse events related to this recall. BACKGROUND: Ibuprofen Lysine Injection is indicated 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 product is packaged in three 2 mL Single-Dose vials per carton.
The product was distributed nationwide to wholesalers and distributors for further distribution to hospitals and retail customers. RECOMMENDATION: X-Gen is notifying its distributors and customers by emails and fax communications and is arranging for return of all recalled products. Consumers/distributors/retailers that have the Ibuprofen Lysine Injection which is being recalled should stop using and return to their wholesaler/distributor, or to X-Gen or to Exela. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert, including a link to the press release, at: You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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