Akebia Therapeutics dba Keryx Biopharmaceutials, Inc: Drug Recall
Recall #D-0170-2021 · 12/09/2020
Class II: Risk
Recall Details
- Recall Number
- D-0170-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
- Status
- Terminated
- Date Initiated
- 12/09/2020
- Location
- Cambridge, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,170 bottles
Reason for Recall
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
Distribution Pattern
The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
Other Recalls by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
- Class III: Low Risk 01/29/2021
View all recalls by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.