Auryxia tablets recalled over manufacturing violations

Recall date

December 9, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc recalls Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHA…

Recall number

D-0170-2021

FDA classification

Class II

Brand / firm

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Sold / distributed

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

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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