Drug recall D-0499-2021

Class II Terminated reported Jun 2, 2021

Product

Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc. 750 Lexington Avenue, 20th Floor New York, NY 10022 USA

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Lots and codes

AN0142D

Recall details

Recalling firm
Cardinal Health Inc., Dublin, OH
Quantity
136 bottles
Distribution
FL, GA, SC
Type
Voluntary: Firm initiated
Recall initiated
March 15, 2021
Terminated
June 17, 2024

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