December 30, 2020
Akebia Therapeutics/Keryx Biopharmaceuticals Inc. is recalling 2170 bottles of Auryxia (ferric citrate) tablets because of deviations from Current Good Manufacturing Practice regulations. The recall was included in the December 30, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 210-mg Auryxia tablets in 200-count bottles (NDC 59922-631-01) from lot 9062 (Exp. 2/21). The tablets were distributed by two major distributors, who further circulated the product nationwide and to one specialty pharmacy.
Akebia Therapeutics/Keryx Biopharmaceuticals Inc. voluntarily initiated the recall December 9, 2020. On December 18, 2020, the FDA designated the recall Class II. Use of products under Class II recall could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Auryxia is a prescription drug used to treat iron deficiency anemia in adults with chronic kidney disease not on dialysis. It is also used to control serum phosphorus levels in adults with chronic kidney disease who are on dialysis.