Why it was recalled
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Product description
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1389-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 10, 2020
- FDA report date
- Jul 22, 2020
- Quantity
- 59,820 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Keryx Biopharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1389-2020, exactly as published.
Show all FDA fields
- City
- Boston
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 86008
- Address
- 1 Marina Park Dr Fl 12
- Code information
- 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.
- Postal code
- 02210-1832
- Report date
- Jul 22, 2020
- Product type
- Drugs
- Recall number
- D-1389-2020
- Classification
- Class II
- Recalling firm
- Keryx Biopharmaceuticals, Inc.
- Product quantity
- 59,820 bottles
- Termination date
- Jan 8, 2021
- Reason for recall
- cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jul 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 15, 2020