Prescription drug
Where is Acetate Ion made?
5 companies sell it under their own name. Their labels name 6 factories in India, the United States and Italy.
India 3United States 2Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. Sodium Acetate164 mg per 1 mL · NDC 0409-3299 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Pfizer Healthcare India Private LimitedMakes it, tests it, packages it and labels it | Anakapalli, India | Problems found, fixed voluntarilyOct 2022 | |
| Amneal Pharmaceuticals Private Limited164 mg per 1 mL · NDC 80830-2436, 80830-2437, 80830-2435 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | No problems foundAug 2024 |
| Fresenius Kabi, LLC4 meq per 100 mL · NDC 63323-032 | Fresenius Kabi USA, LLCMakes it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Milla Pharmaceuticals Inc.164 mg per 1 mL, 200 meq per 100 mL, 400 meq per 100 mL · NDC 71357-002, 71357-007, 71357-008 +1 | S.m. Farmaceutici SRLMakes it | Tito, Italy | Problems found, fixed voluntarilyMar 2026 |
| Somerset Therapeutics, LLC164 mg per 1 mL · NDC 70069-047, 70069-048 | Maiva Pharma Private LimitedMakes it, tests it, packages it and labels it | Hosur, India | Problems found, fixed voluntarilyOct 2022 |
Recalls
- Mar 4, 2022 · Class I · Fresenius Kabi USA, LLC
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.