Heparin Recall News

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Tuesday, July 13, 2010

preservative free heparin approved for infants

The FDA approved a preservative-free Heparin Lock Flush Solution as a safer alternative for intravenous injection devices used in neonates and pediatric patients. The preservative-free Heparin is manufactured by APP Pharmaceuticals, Inc.

Benzyl alcohol, a preservative that is currently used in multiple-dose vial preparations of Heparin Lock Flush Solution, has been associated with toxicity in neonates and has been reported to be associated with a fetal Gasping Syndrome in premature infants

Both the FDA, in concurrence with the American Academy of Pediatrics and the Centers for Disease Control and Prevention, recommends not using intravascular flush solutions containing benzyl alcohol for newborns.

The doses strengths are 10 UPS Units/1 mL and 100 USP Units/1 mL.

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