FDA-Drug2018-01-03Class III
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
Keryx Biopharmaceuticals, Inc.
Hazard
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.
Sold states
Distributed nationwide in the USA
Affected count
2,488 200-bottles
Manufactured in
1 Marina Park Dr Fl 12, N/A, Boston, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0133-2018Don't want to check this manually?
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