Drug recall
Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by…
FDA recall event 87256 · Class III · Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
Key facts
| Event ID | 87256 |
|---|---|
| Recall numbers | D-0260-2021 |
| Recalling firm | Akebia Therapeutics dba Keryx Biopharmaceutials, Inc |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Dissolution Specifications |
| Initiation date | Jan 29, 2021 |
| Report date | Feb 24, 2021 |
| Termination date | Feb 10, 2022 |
| City | Cambridge |
| 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: