Auryxia tablets 210 mg recalled over manufacturing violations
- Recall date
- July 10, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Keryx Biopharmaceuticals, Inc. recalls Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Bi…
- Recall number
- D-1389-2020
- FDA classification
- Class II
- Brand / firm
- Keryx Biopharmaceuticals, Inc.
- Sold / distributed
- Nationwide in the U.S.
Why it was recalled
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.
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