FDA Drug Moderate Class II Terminated

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

Reported: December 30, 2020 Initiated: December 9, 2020 #D-0170-2021

Product Description

Reason for Recall

CGMP Deviations

Details

Recalling Firm: Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
Units Affected: 2,170 bottles
Distribution: The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
Location: Cambridge, MA

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc. Units affected: 2,170 bottles.

Why was this product recalled? ▼

CGMP Deviations

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on December 30, 2020. Severity: Moderate. Recall number: D-0170-2021.