NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter
MedSun: Newsletter #52, September 2010

FDA MedWatch Safety Alert

FDA notified healthcare professionals of a recall of two lots of NeoProfen (ibuprofen lysine) Injection because the product failed to meet a visible particulate quality requirement. NeoProfen is a non-steroidal anti-inflammatory therapy indicated to close a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The recall includes product lots 1734991 (expiration date: April, 2011) and 1922319 (expiration date: March, 2012).

Additional Information:

FDA MedWatch Safety Alert. NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter. August 2, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220798.htm


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