Akebia Therapeutics dba Keryx Biopharmaceutials, Inc Recalls

FDA
2
Total Recalls
1
Agencies
Dec 2020
First Recall
Feb 2021
Latest Recall
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Showing 1-2 of 2 recalls

FDA

Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.

Failed Dissolution Specifications
FDA

Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01

CGMP Deviations