D-0170-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 30, 2020
- Initiation Date
- December 9, 2020
- Termination Date
- September 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