Prescription drug
Where is Bicarbonate Ion made?
16 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 11 factories in the United States, India, Spain and Poland.
United States 6India 3Spain 1Poland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Onpharma, Inc.84 mg per 1 mL · NDC 50509-100 | Alliance Medical Products, Inc. (dba Siegfried Irvine)Makes it | Irvine, CA, United States | Problems found, fixed voluntarilyNov 2025 |
| Avrio Biopharmaceuticals, LLCMakes it | Location not on file | Not inspected on record | |
| WuXi AppTec, Inc.Makes it | Location not on file | Not inspected on record | |
| Amneal Pharmaceuticals Private Limited Sodium Bicarbonate12.6 mg per 1 mL, 84 mg per 1 mL · NDC 80830-2613, 80830-2305 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | No problems foundAug 2024 |
| Anthea Pharma Private Limited84 mg per 1 mL · NDC 83854-001 | Anthea Pharma Private LimitedMakes it | Sangareddy, India | Not inspected on record |
| Baxter Healthcare Corporation sodium bicarbonate12.6 mg per 1 mL · NDC 0338-0822 | Bieffe Medital SAMakes it, tests it, packages it, labels it and sterilizes it | Sabinanigo (Senegue), Spain | Problems found, fixed voluntarilyApr 2025 |
| Caraco Pharmaceutical Laboratories, Ltd.84 mg per 1 mL · NDC 70095-050 | Steriscience SP Z O OMakes it, tests it and packages it | Warszawa, Poland | Problems found, fixed voluntarilyFeb 2024 |
| Civica, Inc.84 mg per 1 mL · NDC 72572-740, 72572-200 | Exela Pharma Sciences, LLC.Makes it, tests it and packages it | Lenoir, NC, United States | Serious problems, FDA actionNov 2024 |
| Exela Pharma Sciences, LLC42 mg per 1 mL, 75 mg per 1 mL, 84 mg per 1 mL · NDC 51754-5012, 51754-5002, 51754-5001 +3 | Exela Pharma Sciences, LLC.Makes it, tests it and packages it | Lenoir, NC, United States | Serious problems, FDA actionNov 2024 |
| Fresenius Kabi, LLC42 mg per 1 mL, 84 mg per 1 mL · NDC 63323-083, 63323-089 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Glenmark Pharmaceuticals Inc., USA84 mg per 1 mL · NDC 68462-951 | Anthea Pharma Private LimitedMakes it | Sangareddy, India | Not inspected on record |
| Hospira, Inc.42 mg per 1 mL · NDC 0409-5555 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| International Medication Systems, Ltd.84 mg per 1 mL · NDC 76329-3352 | International Medication Systems, Ltd.Makes it, tests it and labels it | South El Monte, CA, United States | Serious problems, FDA actionDec 2025 |
| Nomax Inc.977.5 mg · NDC 51801-007, 51801-001, 51801-005 +1 | Nomax, INCMakes it | Saint Louis, MO, United States | Problems found, fixed voluntarilyDec 2022 |
| Omnivium Pharmaceuticals Llc.84 mg per 1 mL · NDC 81665-200 | Maiva Pharma Private LimitedMakes it | Hosur, India | Problems found, fixed voluntarilyOct 2022 |
| Steriscience Specialties Private Limited84 mg per 1 mL · NDC 82449-000 | Steriscience SP Z O OMakes it and tests it | Warszawa, Poland | Problems found, fixed voluntarilyFeb 2024 |
| Long Grove Pharmaceuticals, LLC84 mg per 1 mL · NDC 81298-7620 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Milla Pharmaceuticals Inc.84 mg per 1 mL · NDC 71357-004 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Bicarbonate Ion 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:
50090-6813 - Bryant Ranch Prepack:
72162-2314 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1400,51662-1310,51662-1497,51662-1463+5 - Medical Purchasing Solutions, LLC.:
71872-7097,71872-7310,71872-7371,71872-7376 - ProPharma Distribution:
84549-352,84549-050 - Remedyrepack Inc.:
70518-4158 - US MedSource, LLC:
61699-6625
Recalls
- Jul 30, 2025 · Class II · Exela Pharma Sciences LLC
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. - Mar 7, 2025 · Class II · Exela Pharma Sciences LLC
Lack of Assurance of Sterility - Oct 18, 2023 · Class I · Exela Pharma Sciences LLC
Presence of Particulate Matter: Silicone - Nov 28, 2022 · Class I · Exela Pharma Sciences LLC · 2 recall notices
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. - Oct 4, 2022 · Class I · Exela Pharma Sciences LLC · 2 recall notices
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration - Jan 11, 2022 · Class II · Exela Pharma Sciences LLC
Lack of Assurance of Sterility
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.