Why it was recalled
Failed Dissolution Specifications
Product description
Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.
Lot numbers, UPCs & expiration codes
Lots #: CDKSN, CDPPH, Exp January 2022; Lot #: CDPPK, Exp February 2022.
Where it was sold
Nationwide.
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-0260-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 29, 2021
- FDA report date
- Feb 24, 2021
- Quantity
- 17,664 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
Original FDA data
Every field from FDA enforcement report D-0260-2021, exactly as published.
Show all FDA fields
- City
- Cambridge
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 87256
- Address
- 245 1st St
- Code information
- Lots #: CDKSN, CDPPH, Exp January 2022; Lot #: CDPPK, Exp February 2022.
- Postal code
- 02142-1200
- Report date
- Feb 24, 2021
- Product type
- Drugs
- Recall number
- D-0260-2021
- Classification
- Class III
- Recalling firm
- Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
- Product quantity
- 17,664 bottles
- Termination date
- Feb 10, 2022
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jan 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Feb 17, 2021