Reported Dec 30, 2020 · Terminated

Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX…

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Akebia Therapeutics dba Keryx Biopharmaceutials, Inc · 245 1st St · Cambridge, MA · 02142-1200

Is this the product you have?

  • Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only
  • Manufactured for and distributed byKERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01
Lot codes and dates
  • Lot Number
    • 9062
    • exp. date Feb 2021
Amount recalled
2,170 bottles

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 1, 2021 · Data as of Sep 19, 8:07 PM UTC

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