July 24, 2020
Keryx Biopharmaceuticals Inc. is recalling nearly 60,000 bottles of Auryxia (ferric citrate) tablets, 210 mg, because they were not manufactured in accordance with the approved manufacturing process, according to the July 22, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects Auryxia tablets, 210 mg, 200-count bottles (NDC 59922-631-01) from lots AK6003C (Exp. 10/31/20); AK6004B (Exp. 11/30/20); CBMKF and CBMKH (Exp. 8/31/20); CCKSM (Exp. 9/30/20); CBWKN (Exp. 11/30/20); CCSTZ and CCWZB (Exp. 5/31/21); CCYSF, CCYSG, and CCWZC (Exp. 6/30/21); and CDCTB and CDCSZ (Exp. 7/31/21). Tablets from the lots were distributed throughout the United States.
Keryx Biopharmaceuticals voluntarily initiated the recall July 10, 2020. The FDA designated the recall Class II on July 15, 2020. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Auryxia is a prescription medicine used by adults with chronic kidney disease. Those on dialysis take it for the control of serum phosphorus levels. Those not on dialysis take it to treat iron deficiency anemia.