Medications & Supplements/Prescription Drugs

Keryx Biopharmaceuticals, Inc.: Auryxia (ferric citrate) Tablets Recalled for Manufacturing Deviations

Agency Publication Date: July 15, 2020

Summary

Keryx Biopharmaceuticals, Inc. is recalling approximately 59,820 bottles of Auryxia (ferric citrate) 210 mg tablets because certain lots were not manufactured according to the FDA-approved manufacturing process. This prescription medication is used to treat patients with chronic kidney disease. Consumers who have these specific bottles should check their lot numbers and expiration dates immediately to see if their medication is affected. Because this is a prescription drug, patients should not stop taking their medication without consulting a healthcare professional first.

Risk

The deviation from the approved manufacturing process means the safety, quality, and efficacy of these specific drug lots cannot be guaranteed, potentially impacting the treatment of patients with chronic kidney disease.

What You Should Do

Check your bottle of Auryxia (ferric citrate) 210 mg for the following Lot Numbers and Expiration Dates: AK6003C (Exp. 10/31/2020), AK6004B (Exp. 11/30/2020), CBMKF (Exp. 08/31/2020), CBMKH (Exp. 08/31/2020), CCKSM (Exp. 09/30/2020), CBWKN (Exp. 11/30/2020), CCSTZ (Exp. 05/31/2021), CCWZB (Exp. 05/31/2021), CCYSF (Exp. 06/30/2021), CCYSG (Exp. 06/30/2021), CCWZC (Exp. 06/30/2021), CDCTB (Exp. 07/31/2021), or CDCSZ (Exp. 07/31/2021).
Verify if your bottle has the National Drug Code (NDC) 59922-631-01 printed on the label.
If you have an affected bottle, contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a replacement.
Return any unused portions of the recalled medication to your pharmacy for a refund.
Contact Keryx Biopharmaceuticals, Inc. at their Boston headquarters for further instructions on the recall process.
For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Auryxia (ferric citrate) tablets 210 mg (200 tablets per bottle)

Model:

NDC: 59922-631-01

Recall #: D-1389-2020

Lot Numbers:

AK6003C (Exp. 10/31/2020)

AK6004B (Exp. 11/30/2020)

CBMKF (Exp. 08/31/2020)

CBMKH (Exp. 08/31/2020)

CCKSM (Exp. 09/30/2020)

CBWKN (Exp. 11/30/2020)

CCSTZ (Exp. 05/31/2021)

CCWZB (Exp. 05/31/2021)

CCYSF (Exp. 06/30/2021)

CCYSG (Exp. 06/30/2021)

CCWZC (Exp. 06/30/2021)

CDCTB (Exp. 07/31/2021)

CDCSZ (Exp. 07/31/2021)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86008

Status: Resolved

Manufacturer: Keryx Biopharmaceuticals, Inc.

Sold By: pharmacies nationwide

Manufactured In: United States

Units Affected: 59,820 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your bottle of Auryxia (ferric citrate) 210 mg for the following Lot Numbers and Expiration Dates: AK6003C (Exp. 10/31/2020), AK6004B (Exp. 11/30/2020), CBMKF (Exp. 08/31/2020), CBMKH (Exp. 08/31/2020), CCKSM (Exp. 09/30/2020), CBWKN (Exp. 11/30/2020), CCSTZ (Exp. 05/31/2021), CCWZB (Exp. 05/31/2021), CCYSF (Exp. 06/30/2021), CCYSG (Exp. 06/30/2021), CCWZC (Exp. 06/30/2021), CDCTB (Exp. 07/31/2021), or CDCSZ (Exp. 07/31/2021).

Verify if your bottle has the National Drug Code (NDC) 59922-631-01 printed on the label.

If you have an affected bottle, contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a replacement.

Return any unused portions of the recalled medication to your pharmacy for a refund.

Contact Keryx Biopharmaceuticals, Inc. at their Boston headquarters for further instructions on the recall process.

For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Auryxia (ferric citrate) tablets 210 mg (200 tablets per bottle)

Model:

NDC: 59922-631-01

Recall #: D-1389-2020

Lot Numbers:

AK6003C (Exp. 10/31/2020)

AK6004B (Exp. 11/30/2020)

CBMKF (Exp. 08/31/2020)

CBMKH (Exp. 08/31/2020)

CCKSM (Exp. 09/30/2020)

CBWKN (Exp. 11/30/2020)

CCSTZ (Exp. 05/31/2021)

CCWZB (Exp. 05/31/2021)

CCYSF (Exp. 06/30/2021)

CCYSG (Exp. 06/30/2021)

CCWZC (Exp. 06/30/2021)

CDCTB (Exp. 07/31/2021)

CDCSZ (Exp. 07/31/2021)