Reported Feb 24, 2021 · Terminated

Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX…

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 tablets bottle, RX ONLY
  • Manufactured for and distributed byKERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01
Lot codes and dates
  • Lots #: CDKSN, CDPPH, Exp January 2022; Lot #: CDPPK, Exp February 2022.
Amount recalled
17,664 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 10, 2022 · Data as of Sep 19, 8:09 PM UTC

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