January 05, 2018
Keryx Biopharmaceuticals is recalling 200-count bottles of Auryxia (ferric citrate) tablets (NDC 59922-631-01) following reports that silica gel granules from damaged StripPax packets may have mixed with tablets in the bottles, according to the January 3, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 2488 bottles from lot AH3842, which was distributed throughout the United States.
Keryx Biopharmaceuticals voluntarily initiated the recall December 12, 2017. Two weeks later, the FDA designated it Class III, suggesting use of the affected product is not likely to cause harm.
Auryxia is a prescription phosphate binder used to control serum phosphorus levels in adults with severe kidney disease on dialysis. In November 2017, the FDA granted it an additional indication for the treatment of iron deficiency anemia in adults with chronic kidney disease not on dialysis.
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