February 26, 2021
Keryx Biopharmaceuticals Inc is recalling 17,664 bottles of Auryxia (ferric citrate) tablets because samples failed to meet dissolution specifications during testing, according to the February 24, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 200-count bottles of 210-mg Auryxia tablets (NDC 59922-0631-01) from lots CDKSN (Exp. 1/22), CDPPH (Exp. 1/22), and CDPPK (Exp. 2/22). The tablets were distributed throughout the United States.
Akebia Therapeutics, which does business as Keryx Biopharmaceuticals, voluntarily initiated the recall January 29, 2021. The FDA designated the recall Class III on February 17, 2021, suggesting use of the recalled tablets is not likely to cause harm.
Auryxia is a prescription medication used to control serum phosphorus levels of adults with chronic kidney disease on dialysis and to treat iron deficiency anemia in adults with chronic kidney disease not on dialysis.