Auryxia (ferric citrate)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

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

Affected NDC 59922-0631-01

Compare with the code on your package — it is the most precise check available.

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Auryxia ferric citrate NDC 59922-0631	TETRAFERRIC TRICITRATE DECAHYDRATE 210 mg/1	Tablet, Film Coated Oral	Akebia Therapeutics, Inc.	Rx

Recalling firm: Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
NDC code: 59922-631-01
Origin: MA, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0170-2021 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

All 2020 recalls

Jan 29, 2021 Class III · Low risk