December 2017 FDA Recall Auryxia by Keryx Biopharmaceuticals, Inc.
D-0133-2018 - Presence of Foreign Substance

This Class III drug recall was voluntarily initiated by Keryx Biopharmaceuticals, Inc. on December 12, 2017 for the product Auryxia. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0133-2018

Reason for Recall
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Initiated
12-12-2017
Reported
01-03-2018
Quantity
2,488 200-bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78773
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.
Keryx Biopharmaceuticals, 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.
Distributed nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-01-2018
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 Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01

Batch or Lot Expiration Information

Lot# AH3842

Affected Packages Involved in this Recall

59922-631-01 Auryxia