Drug recall D-0170-2021

Class II Terminated reported Dec 30, 2020

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

Lots and codes

Lot Number: 9062, exp. date Feb 2021

Recall details

Recalling firm
Akebia Therapeutics dba Keryx Biopharmaceutials, Inc, Cambridge, MA
Quantity
2,170 bottles
Distribution
The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.
Type
Voluntary: Firm initiated
Recall initiated
December 9, 2020
Terminated
September 1, 2021

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