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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc: Auryxia (ferric citrate) Tablets Recalled for Manufacturing Deviations

Agency Publication Date: December 18, 2020
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Summary

Akebia Therapeutics is recalling 2,170 bottles of Auryxia (ferric citrate) 210 mg tablets because of deviations from Current Good Manufacturing Practice (CGMP) standards. This prescription medication is used to control phosphorus levels in adults with chronic kidney disease on dialysis. The recall affects 200-count bottles from lot number 9062 with an expiration date of February 2021 that were distributed nationwide. Consumers should contact their healthcare provider or pharmacist regarding the use of this medication.

Risk

The recall is due to manufacturing deviations that may affect the quality and safety of the drug. While no specific injuries have been reported, failing to meet manufacturing standards can lead to products that do not meet their required specifications for strength, quality, or purity.

What You Should Do

  1. Check your prescription bottle for Auryxia (ferric citrate) 210 mg tablets in 200-count bottles.
  2. Verify if your bottle belongs to Lot Number 9062 with an expiration date of February 2021 (Exp. Feb 2021).
  3. If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on whether to continue or change your medication.
  4. Return any unused portion of the affected lot to the pharmacy where you purchased it for a refund.
  5. Contact Akebia Therapeutics (dba Keryx Biopharmaceuiticals) or the distributor for further instructions regarding this recall.
  6. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare 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-count bottles)
Model:
NDC 59922-631-01
Recall #: D-0170-2021
Lot Numbers:
9062 (exp. date Feb 2021)
Date Ranges: February 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86955
Status: Resolved
Manufacturer: Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
Sold By: specialty pharmacy; major distributors
Manufactured In: United States
Units Affected: 2,170 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 ยท 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.