D-0260-2021 Class III Terminated

Recalled by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc — Cambridge, MA

Recall Details

Product Type
Drugs
Report Date
February 24, 2021
Initiation Date
January 29, 2021
Termination Date
February 10, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17,664 bottles

Product Description

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 Pattern

Nationwide.

Code Information

Lots #: CDKSN, CDPPH, Exp January 2022; Lot #: CDPPK, Exp February 2022.