FDA recall D-0260-2021

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc · Class III · drug

Product

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.

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2021-01-29
Report date: 2021-02-24
Termination date: 2022-02-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0260-2021