Class II · Moderate risk
Auryxia (ferric citrate)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
National Drug Code
Is NDC 59922-0631-01 recalled?
Auryxia · 200 TABLET, FILM COATED in 1 BOTTLE (59922-631-01)
Yes — this exact package was recalled
5 FDA recalls name the code 59922-0631-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- ferric citrate
- Strength
- TETRAFERRIC TRICITRATE DECAHYDRATE 210 mg/1
- Form
- Tablet, Film Coated · Oral
- Labeler
- Akebia Therapeutics, Inc.
- Type
- Human Prescription Drug
- Product code
- 59922-0631
Recalls naming this package
Class III · Low risk
Auryxia (ferric citrate)
Failed Dissolution Specifications
Class II · Moderate risk
Auryxia (ferric citrate)
CGMP Deviations
Class II · Moderate risk
Auryxia (ferric citrate)
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
Class III · Low risk
Auryxia (ferric citrate)
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.