D-1389-2020 Class II Terminated
FDA drug recall D-1389-2020 was initiated by Keryx Biopharmaceuticals, Inc. on July 10, 2020 and is designated Class II. Reason for recall: cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia. The recall status is terminated (terminated January 8, 2021). Affected quantity: 59,820 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 22, 2020
- Initiation Date
- July 10, 2020
- Termination Date
- January 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59,820 bottles
Product Description
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.
Reason for Recall
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #s: AK6003C, Exp. 10/31/2020; AK6004B, Exp. 11/30/2020; CBMKF, CBMKH, Exp. 08/31/2020; CCKSM, Exp. 09/30/2020; CBWKN, Exp. 11/30/2020; CCSTZ, CCWZB, Exp. 05/31/2021; CCYSF, CCYSG, CCWZC, Exp. 06/30/2021; CDCTB, CDCSZ, Exp. 07/31/2021.