Parenteral Iron Replacement, Phosphate Binder
Where is Ferric Cation made?
20 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 10 factories in the United States, Switzerland, Portugal, Italy, France and the United Kingdom.
United States 5Switzerland 1Portugal 1Italy 1France 1United Kingdom 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| American Regent, Inc. Venofer, Injectafer20 mg per 1 mL, 50 mg per 1 mL · NDC 0517-2325, 0517-2340, 0517-2310 +3 | American Regent, Inc.Makes it | Hilliard, OH, United States | Problems found, fixed voluntarilyJun 2026 |
| American Regent, Inc.Makes it and tests it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 | |
| Vifor (International) Inc.Makes it and makes the active ingredient | St. Gallen, Switzerland | Problems found, fixed voluntarilySep 2024 | |
| Fresenius Medical Care Holdings, Inc. Venofer20 mg per 1 mL · NDC 49230-530, 49230-534 | American Regent, Inc.Makes it | Hilliard, OH, United States | Problems found, fixed voluntarilyJun 2026 |
| American Regent, Inc.Makes it and tests it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 | |
| Vifor (International) Inc.Makes it and makes the active ingredient | St. Gallen, Switzerland | Problems found, fixed voluntarilySep 2024 | |
| Sandoz Inc.50 mg per 1 mL, 50 mg per 2.5 mL, 100 mg per 5 mL, 200 mg per 10 mL · NDC 0781-3486, 0781-3487, 0781-3542 +1 | American Regent, Inc.Makes it | Hilliard, OH, United States | Problems found, fixed voluntarilyJun 2026 |
| Vifor (International) Inc.Makes the active ingredient | St. Gallen, Switzerland | Problems found, fixed voluntarilySep 2024 | |
| Shield TX (UK) Ltd Accrufer30 mg · NDC 73059-001 | Patheon France S.A.SMakes it, tests it, packages it and labels it | Bourgoin Jallieu, France | Problems found, fixed voluntarilySep 2023 |
| Sterling Pharma Solutions LimitedMakes the active ingredient | Cramlington, United Kingdom | Problems found, fixed voluntarilyJul 2025 | |
| Biodiagnostic International20 g per 100 g · NDC 42721-112 | International Bio DiagnosticMakes it | Location not on file | Not inspected on record |
| Gynex Corporation210 mg per 1 g · NDC 48992-001 | Diversified Chemical ProductsMakes it | Wilmington, DE, United States | Problems found, fixed voluntarilyJan 2025 |
| Hikma Pharmaceuticals USA Inc.12.5 mg per 1 mL · NDC 0143-9298, 0143-9570 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| International Medication Systems, Ltd.20 mg per 1 mL · NDC 76329-9200, 76329-9201, 76329-9202 | International Medication Systems, Ltd.Makes it and tests it | South El Monte, CA, United States | Serious problems, FDA actionDec 2025 |
| Island Kinetics, Inc. d.b.a. CoValence Laboratories1 g per 1 g · NDC 66915-301 | Island Kinetics, Inc. d.b.a. CoValence LaboratoriesMakes it | Chandler, AZ, United States | Serious problems, FDA actionJan 2026 |
| Premier Dental Products Company210 mg per 1 g · NDC 48783-113, 48783-112 | Diversified Chemical ProductsMakes it | Wilmington, DE, United States | Problems found, fixed voluntarilyJan 2025 |
| Sanofi-Aventis U.S. LLC Ferrlecit12.5 mg per 1 mL · NDC 0024-2792, 0024-2794 | Sanofi S.r.l.Makes it, tests it, packages it and labels it | Anagni, Italy | Problems found, fixed voluntarilyOct 2024 |
| Akebia Therapeutics, Inc. Auryxia210 mg · NDC 59922-631 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Allergan, Inc. INFeD50 mg per 1 mL · NDC 0023-6082 | The label doesn't name the factory. Plants this company names for other drugs | ||
| CooperSurgical, Inc.259 mg per 1 g · NDC 59365-5006, 59365-6065 | The label doesn't name the factory. Plants this company names for other drugs | ||
| MedGyn Products, Inc.20 g per 100 mL · NDC 70880-112 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Institutional LLC50 mg per 1 mL, 50 mg per 2.5 mL, 100 mg per 5 mL, 200 mg per 10 mL · NDC 67457-638, 67457-639, 67457-797 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.210 mg · NDC 0378-2895 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Purtex Inc1 g · NDC 70804-112 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Rockwell Medical Inc. Triferic AVNU, Triferic1.5 mg per 1 mL, 5.44 mg per 1 mL, 272 mg · NDC 57278-318, 57278-315, 57278-314 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.210 mg · NDC 0480-2996 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ferric Cation in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-4541 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1568,51662-1441 - Henry Schein, Inc.:
0404-9879
Recalls
- Apr 14, 2026 · Class III · Premier Dental Products Co
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box… - Nov 11, 2024 · Class II · American Regent, Inc. · 3 recall notices
Presence of Particulate Matter: Potential for glass delamination from the vials. - Aug 9, 2023 · Class II · Ecometics, Inc.
CGMP Deviations: Products not manufactured under current good manufacturing practices. - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Dec 9, 2020 · Class II · Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
CGMP Deviations - Jul 10, 2020 · Class II · Keryx Biopharmaceuticals, Inc.
cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia. - Jul 3, 2018 · Class II · Medgyn Products, Inc.
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices. - Jun 11, 2018 · Class II · BioDiagnostic International
CGMP Deviations: Products not manufactured under current good manufacturing practices. - Dec 12, 2017 · Class III · Keryx Biopharmaceuticals, Inc.
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. - Nov 17, 2016 · Class III · West-Ward Pharmaceuticals Corp.
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.