Home / Recalls / Keryx Biopharmaceuticals, Inc. / D-0133-2018

D-0133-2018 Class III Terminated

Recalled by Keryx Biopharmaceuticals, Inc. — Boston, MA

Recall Details

Product Type: Drugs
Report Date: January 3, 2018
Initiation Date: December 12, 2017
Termination Date: October 1, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,488 200-bottles

Product Description

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

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.

Distribution Pattern

Distributed nationwide in the USA

Code Information

Lot # AH3842