FDA-Drug2020-07-22Class II
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.
Keryx Biopharmaceuticals, Inc.
Hazard
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Sold states
Nationwide in the U.S.
Affected count
59,820 bottles
Manufactured in
1 Marina Park Dr Fl 12, N/A, Boston, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1389-2020Don't want to check this manually?
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