Drug product
Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.
D-0260-2021
Product summary
- Event
- Event 87256
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,664 bottles
- Official record key
drug-enforcement:D-0260-2021
Official wording
Reason: Failed Dissolution Specifications
Code information: Lots #: CDKSN, CDPPH, Exp January 2022; Lot #: CDPPK, Exp February 2022.
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications