Cambridge, MA, United States
Akebia Therapeutics dba Keryx Biopharmaceutials, Inc recalls
2 recalls recorded since 2018, most recently on 29 January 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 29 January 2021
- Terminated
- 10 February 2022
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0260-2021
- 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.
Terminated Class II Drugs
- Recall started
- 9 December 2020
- Terminated
- 1 September 2021
- Reason
- CGMP Deviations
- Distribution
- The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0170-2021
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.