D-0260-2021 Class III Terminated
FDA drug recall D-0260-2021 was initiated by Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc on Jan 29, 2021 and is designated Class III. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated Feb 10, 2022). Affected quantity: 17,664 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 24, 2021
- Initiation Date
- Jan 29, 2021
- Termination Date
- Feb 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,664 bottles
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.
Reason for recall
Failed Dissolution Specifications
Distribution pattern
Nationwide.
Code information
Lots #: CDKSN, CDPPH, Exp January 2022; Lot #: CDPPK, Exp February 2022.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0260-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026