Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.

FDA recall notice · announced February 24, 2021 · Akebia Therapeutics Dba Keryx Biopharmaceutials

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.

Reason for recall

Failed Dissolution Specifications

Notes

Distribution: Nationwide.
Lot/code information: Lots #: CDKSN, CDPPH, Exp January 2022; Lot #: CDPPK, Exp February 2022.
Quantity: 17,664 bottles
Status: Terminated
Products in this recall event:
- Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC (D-0260-2021)

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