Keryx Biopharmaceuticals, Inc. recalls Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Bio
Recalled July 22, 2020 · FDA recall D-1389-2020 · Keryx Biopharmaceuticals
Hazard
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia. · FDA Class II
Units
59,820 bottles
Sold at
Nationwide in the U.S.
Description
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Product
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.
Manufacturer(s)
Keryx Biopharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →