Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.

Recall Number: D-0260-2021

Firm: Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Classification: Class III

Status: Terminated

Report Date: 20210224

Initiation Date: 20210129

Termination Date: 20220210

Failed Dissolution Specifications

Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.