Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distr...
FDA Recall #D-0133-2018 — Class III — December 12, 2017
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.
Recalling Firm
Keryx Biopharmaceuticals, Inc. — Boston, MA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
2,488 200-bottles
Distribution
Distributed nationwide in the USA
Code Information
Lot # AH3842
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated