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# Exela Pharma Recalls Ibuprofen Lysine Injection
- URL: https://www.fdaweb.com/exela-pharma-recalls-ibuprofen-lysine-injection/
- Published: 2017-02-09T12:00:00.000Z
- Updated: 2026-09-14T22:05:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137942

Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, has recalled one lot (PLND1613) of ibuprofen lysine injection, 20mg/2mL (10mg/mL) because some 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,” a [recall notice](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm540828.htm?ref=fdaweb.com) says. Ibuprofen lysine injection is indicated to close a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500 grams, who are no more than 32 weeks gestational age when usual medical management is ineffective.