Drug recall
Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by…
FDA recall event 86008 · Class II · Keryx Biopharmaceuticals, Inc.
Key facts
| Event ID | 86008 |
|---|---|
| Recall numbers | D-1389-2020 |
| Recalling firm | Keryx Biopharmaceuticals, Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia. |
| Initiation date | Jul 10, 2020 |
| Report date | Jul 22, 2020 |
| Termination date | Jan 8, 2021 |
| City | Boston |
| State | MA |
| Country | United States |
| FEI number | 3012772815 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: