Keryx Biopharmaceuticals recalls
FDA enforcement reports naming Keryx Biopharmaceuticals, Inc. as the recalling firm.
- Recall reports
- 2
- Class I (serious)
- 0
- Most recent report
- Jul 22, 2020
- Jul 22, 2020Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured…Drug · Keryx Biopharmaceuticals, Inc.cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.Class II
- Jan 3, 2018Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for…Drug · Keryx Biopharmaceuticals, Inc.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.Class III