January 2021 FDA Recall Drug by Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc
D-0260-2021 - Failed Dissolution Specifications

This Class III drug recall was voluntarily initiated by Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc on January 29, 2021 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0260-2021

Reason for Recall
Failed Dissolution Specifications
Initiated
01-29-2021
Reported
02-24-2021
Quantity
17,664 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87256
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2022
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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