D-0499-2021 Class II Terminated
FDA drug recall D-0499-2021 was initiated by Cardinal Health Inc. on March 15, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage. The recall status is terminated (terminated June 17, 2024). Affected quantity: 136 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 2, 2021
- Initiation Date
- March 15, 2021
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136 bottles
Product Description
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.
Distribution Pattern
FL, GA, SC
Code Information
AN0142D