Home / Recalls / Keryx Biopharmaceuticals, Inc. / D-1389-2020

D-1389-2020 Class II Terminated

Recalled by Keryx Biopharmaceuticals, Inc. — Boston, MA

Recall Details

Product Type: Drugs
Report Date: July 22, 2020
Initiation Date: July 10, 2020
Termination Date: January 8, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 59,820 bottles

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the U.S.

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.