Auryxia Tablet, Film Coated
FDA Recall NDC 59922-631
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Auryxia (NDC 59922-631). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Akebia Therapeutics, Inc.. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
136 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc. 750 Lexington Avenue, 20th Floor New York, NY 10022 USA
Batch or Lot Expiration Information
Lot# AN0142D
Affected Packages Involved in this Recall
59922-631-01Product
Class II Terminated
CGMP Deviations
Dec 09, 2020
Dec 30, 2020
2,170 bottles
Recall Profile & Regulatory Data
Event ID
86955
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
Termination Date
Sep 01, 2021
Product Description
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
Batch or Lot Expiration Information
Lot# Lot Number: 9062, exp. date Feb 2021
Affected Packages Involved in this Recall
59922-631-01Product
Class II Terminated
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Jul 10, 2020
Jul 22, 2020
59,820 bottles
Recall Profile & Regulatory Data
Event ID
86008
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Keryx Biopharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Jan 08, 2021
Product Description
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.
Batch or Lot Expiration Information
Lot# s: AK6003C, Exp. 10/31/2020; AK6004B, Exp. 11/30/2020; CBMKF, CBMKH, Exp. 08/31/2020; CCKSM, Exp. 09/30/2020; CBWKN, Exp. 11/30/2020; CCSTZ, CCWZB, Exp. 05/31/2021; CCYSF, CCYSG, CCWZC, Exp. 06/30/2021; CDCTB, CDCSZ, Exp. 07/31/2021.
Affected Packages Involved in this Recall
59922-631-01Product
Class III Terminated
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Dec 12, 2017
Jan 03, 2018
2,488 200-bottles
Recall Profile & Regulatory Data
Event ID
78773
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Keryx Biopharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed nationwide in the USA
Termination Date
Oct 01, 2018
Product Description
Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01
Batch or Lot Expiration Information
Lot# AH3842
Affected Packages Involved in this Recall
59922-631-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
