Drug recall D-1389-2020
Product
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.
Lots and codes
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.
Recall details
- Recalling firm
- Keryx Biopharmaceuticals, Inc., Boston, MA
- Quantity
- 59,820 bottles
- Distribution
- Nationwide in the U.S.
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 10, 2020
- Terminated
- January 8, 2021
Related products
- Auryxia – drug information
- NDC 59922-631 Auryxia · Tetraferric Tricitrate Decahydrate 210 mg/1 · Akebia Therapeutics, Inc.