Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01

Recall Number: D-0170-2021

Firm: Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Classification: Class II

Status: Terminated

Report Date: 20201230

Initiation Date: 20201209

Termination Date: 20210901

CGMP Deviations

Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01