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.

FDA recall notice · announced July 22, 2020 · Keryx Biopharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.

Notes

Distribution: Nationwide in the U.S.
Lot/code information: 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.
Quantity: 59,820 bottles
Status: Terminated
Products in this recall event:
- 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: 59 (D-1389-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.