Keryx Biopharmaceuticals, Inc. recalls Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Bioph…
- Recall date
- December 12, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0133-2018
- FDA classification
- Class III
- Brand / firm
- Keryx Biopharmaceuticals, Inc.
- Sold / distributed
- Distributed nationwide in the USA
Why it was recalled
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 means the product violates regulations but is not likely to cause harm.
What was recalled
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
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