Reported Jul 22, 2020 · Terminated
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx…
Keryx Biopharmaceuticals, 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: Keryx Biopharmaceuticals, Inc. · 1 Marina Park Dr Fl 12 · Boston, MA · 02210-1832
Is this the product you have?
Auryxia (ferric citrate) tablets 210 mgRx Only200 tablets per bottle
- Manufactured for and distributed byKeryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142
- NDC59922-631-01
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 AK6003C, Exp. 10/31/2020 2 AK6004B, Exp. 11/30/2020 3 CBMKF, CBMKH, Exp. 08/31/2020 4 CCKSM, Exp. 09/30/2020 5 CBWKN, Exp. 11/30/2020 6 CCSTZ, CCWZB, Exp. 05/31/2021 7 CCYSF, CCYSG, CCWZC, Exp. 06/30/2021 8 CDCTB, CDCSZ, Exp. 07/31/2021. - Amount recalled
- 59,820 bottles
Where it was sold
- Nationwide
Why it was recalled
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
This product could cause temporary or reversible health problems — stop using it.
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