Recalls / Class II
Class IID-0170-2021
Product
Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, 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 Number: 9062, exp. date Feb 2021
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
- Manufacturer
- Akebia Therapeutics, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 245 1st St, N/A, Cambridge, Massachusetts 02142-1200
Distribution
- Quantity
- 2,170 bottles
- Distribution pattern
- The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
Timeline
- Recall initiated
- 2020-12-09
- FDA classified
- 2020-12-18
- Posted by FDA
- 2020-12-30
- Terminated
- 2021-09-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0170-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.