Why it was recalled
CGMP Deviations
Product description
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
Lot numbers, UPCs & expiration codes
Lot Number: 9062, exp. date Feb 2021
Where it was sold
The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
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-0170-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 9, 2020
- FDA report date
- Dec 30, 2020
- Quantity
- 2,170 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
Original FDA data
Every field from FDA enforcement report D-0170-2021, exactly as published.
Show all FDA fields
- City
- Cambridge
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 86955
- Address
- 245 1st St
- Code information
- Lot Number: 9062, exp. date Feb 2021
- Postal code
- 02142-1200
- Report date
- Dec 30, 2020
- Product type
- Drugs
- Recall number
- D-0170-2021
- Classification
- Class II
- Recalling firm
- Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
- Product quantity
- 2,170 bottles
- Termination date
- Sep 1, 2021
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
- Recall initiation date
- Dec 9, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 18, 2020