December 2020 FDA Recall Auryxia by Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc
D-0170-2021 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc on December 9, 2020 for the product Auryxia. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0170-2021

Reason for Recall
CGMP Deviations
Initiated
12-09-2020
Reported
12-30-2020
Quantity
2,170 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86955
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-01-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot Number: 9062, exp. date Feb 2021

Affected Packages Involved in this Recall

59922-631-01 Auryxia