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

FDA recall notice · announced December 30, 2020 · Akebia Therapeutics Dba Keryx Biopharmaceutials

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

CGMP Deviations

Notes

Distribution: The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
Lot/code information: Lot Number: 9062, exp. date Feb 2021
Quantity: 2,170 bottles
Status: Terminated
Products in this recall event:
- 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 5992 (D-0170-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.