Recalls / Class III
Class IIID-0133-2018
Product
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
- Brand name
- Auryxia
- Generic name
- Ferric Citrate
- Active ingredient
- Tetraferric Tricitrate Decahydrate
- Route
- Oral
- NDC
- 59922-631
- FDA application
- NDA205874
- Affected lot / code info
- Lot # AH3842
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.
Recalling firm
- Firm
- Keryx Biopharmaceuticals, Inc.
- Manufacturer
- Akebia Therapeutics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Marina Park Dr Fl 12, N/A, Boston, Massachusetts 02210-1832
Distribution
- Quantity
- 2,488 200-bottles
- Distribution pattern
- Distributed nationwide in the USA
Timeline
- Recall initiated
- 2017-12-12
- FDA classified
- 2017-12-26
- Posted by FDA
- 2018-01-03
- Terminated
- 2018-10-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0133-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.