FDA recall D-1389-2020

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.

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.

Key facts

Status

Terminated

Initiation date

2020-07-10

Report date

2020-07-22

Termination date

2021-01-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boston, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1389-2020