D-0170-2021 Class II Terminated
FDA drug recall D-0170-2021 was initiated by Akebia Therapeutics Dba Keryx Biopharmaceutials, Inc on Dec 9, 2020 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Sep 1, 2021). Affected quantity: 2,170 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 30, 2020
- Initiation Date
- Dec 9, 2020
- Termination Date
- Sep 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,170 bottles
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
Reason for recall
CGMP Deviations
Distribution pattern
The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
Code information
Lot Number: 9062, exp. date Feb 2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0170-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026