Recalls / Class II
Class IID-1389-2020
Product
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, 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 #s: AK6003C, Exp. 10/31/2020; AK6004B, Exp. 11/30/2020; CBMKF, CBMKH, Exp. 08/31/2020; CCKSM, Exp. 09/30/2020; CBWKN, Exp. 11/30/2020; CCSTZ, CCWZB, Exp. 05/31/2021; CCYSF, CCYSG, CCWZC, Exp. 06/30/2021; CDCTB, CDCSZ, Exp. 07/31/2021.
Why it was recalled
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
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
- 59,820 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-07-10
- FDA classified
- 2020-07-15
- Posted by FDA
- 2020-07-22
- Terminated
- 2021-01-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1389-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.