Reported Jan 3, 2018 · Terminated

Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx…

Keryx Biopharmaceuticals, 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: Keryx Biopharmaceuticals, Inc. · 1 Marina Park Dr Fl 12 · Boston, MA · 02210-1832

Is this the product you have?

  • Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY
  • Manufactured for and distributed byKeryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01
Lot codes and dates
  • Lot # AH3842
Amount recalled
2,488 200-bottles

Where it was sold

  • Nationwide

Why it was recalled

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.

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 Oct 1, 2018 · Data as of Sep 19, 6:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.