PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: February 24, 2021 Initiated: January 29, 2021 #D-0260-2021

Product Description

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.

Reason for Recall

Failed Dissolution Specifications

Details

Units Affected
17,664 bottles
Distribution
Nationwide.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc. Units affected: 17,664 bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on February 24, 2021. Severity: Low. Recall number: D-0260-2021.