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.
Check against the official notice below — it lists the full affected range.
Keryx Biopharmaceuticals, Inc. is recalling Auryxia (ferric citrate) 210 mg tablets nationwide in the U.S. The recall involves 59,820 bottles across multiple lot numbers with expiration dates ranging from August 2020 to July 2021. The affected lots were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
The specific lot numbers subject to recall are: AK6003C (Exp. 10/31/2020), AK6004B (Exp. 11/30/2020), CBMKF and CBMKH (Exp. 08/31/2020), CCKSM (Exp. 09/30/2020), CBWKN (Exp. 11/30/2020), CCSTZ and CCWZB (Exp. 05/31/2021), CCYSF, CCYSG, and CCWZC (Exp. 06/30/2021), and CDCTB and CDCSZ (Exp. 07/31/2021). The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Reason for recall: cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia. Distribution: Nationwide in the U.S. Quantity: 59,820 bottles Lot/code info: 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.