Drug product
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
D-0170-2021
Product summary
- Event
- Event 86955
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,170 bottles
- Official record key
drug-enforcement:D-0170-2021
Official wording
Reason: CGMP Deviations
Code information: Lot Number: 9062, exp. date Feb 2021
Distribution pattern: The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations