FDAFDA · Food and drugs·Recall number D-1389-2020
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.
Published July 22, 2020 · Recall initiated: July 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AURYXIA
- Manufacturer
- Keryx Biopharmaceuticals, Inc.
- Distributor
- Nationwide in the U.S.
- Lot
- Lot #s: AK6003C, Exp. 10/31/2020; AK6004B, Exp. 11/30/2020; CBMKF, CBMKH, Exp. 08/31/2020; CCKSM, Exp. 09/30/2020; CBWKN, Exp. 11/30/2020; CCSTZ, CCWZB, Exp. 05/31/2021; CCYSF, CCYSG, CCWZC, Exp. 06/30/2021; CDCTB, CDCSZ, Exp. 07/31/2021.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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