FDA recall D-0170-2021

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

Product

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

Reason for recall

CGMP Deviations

Distribution

The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.

Key facts

Status: Terminated
Initiation date: 2020-12-09
Report date: 2020-12-30
Termination date: 2021-09-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0170-2021