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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