Recalls / Class II
Class IID-0499-2021
Product
Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc. 750 Lexington Avenue, 20th Floor New York, NY 10022 USA
- Brand name
- Auryxia
- Generic name
- Ferric Citrate
- Active ingredient
- Tetraferric Tricitrate Decahydrate
- Route
- Oral
- NDC
- 59922-631
- FDA application
- NDA205874
- Affected lot / code info
- AN0142D
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Akebia Therapeutics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 136 bottles
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0499-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.