Phosphodiesterase 3 Inhibitor
Where is Milrinone made?
13 companies sell it under their own name. Their labels name 10 factories in China, India, the United States and Portugal.
China 4India 3United States 2Portugal 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC1 mg per 1 mL · NDC 63323-617 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Huzhou Zhanwang Pharmaceutical Co., Ltd.Makes the active ingredient | Huzhou, China | No problems foundMar 2024 | |
| Hospira, Inc.0.2 mg per 1 mL, 1 mg per 1 mL · NDC 0409-2045, 0409-1983, 0409-0212 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Wuhan Biocause Pharmaceutical Development Co., LtdMakes the active ingredient | Wuhan, China | Problems found, fixed voluntarilyMar 2025 | |
| Armas Pharmaceuticals Inc.1 mg per 1 mL · NDC 72485-501, 72485-502, 72485-503 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| AuroMedics Pharma LLC0.2 mg per 1 mL · NDC 55150-287, 55150-288 | Eugia Pharma Specialities LimitedMakes it and tests it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Baxter Healthcare Corporation0.2 mg per 1 mL · NDC 0338-6010, 0338-6011 | Baxter Healthcare CorporationMakes it, tests it, packages it, labels it and sterilizes it | Jayuya, PR, United States | Problems found, fixed voluntarilyJul 2024 |
| Caplin Steriles Limited0.2 mg per 1 mL, 1 mg per 1 mL · NDC 65145-176, 65145-177, 65145-120 +2 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Gland Pharma Limited0.2 mg per 1 mL, 1 mg per 1 mL · NDC 68083-410, 68083-411, 68083-318 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Hikma Pharmaceuticals USA Inc.1 mg per 1 mL, 200 ug per 1 mL · NDC 0143-9326, 0143-9374, 0143-9373 +5 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Meitheal Pharmaceuticals Inc.1 mg per 1 mL · NDC 71288-200 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Mullan Pharmaceutical Inc.1 mg per 1 mL · NDC 83301-0016, 83301-0017, 83301-0018 | Shandong New Time Pharmaceutical Co., Ltd.Makes it | Linyi, China | Problems found, fixed voluntarilyJul 2024 |
| Shandong New Time Pharmaceutical Co., Ltd.1 mg per 1 mL · NDC 42677-314, 42677-313, 42677-338 | Shandong New Time Pharmaceutical Co., Ltd.Makes it | Linyi, China | Problems found, fixed voluntarilyJul 2024 |
| Somerset Therapeutics, LLC0.2 mg per 1 mL, 1 mg per 1 mL · NDC 70069-872, 70069-873, 70069-807 +2 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Sagent Pharmaceuticals0.2 mg per 1 mL · NDC 25021-313 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Aug 14, 2023 · Class III · Caplin Steriles Limited
Failed Impurities/Degradation Specifications - May 15, 2017 · Class II · Baxter Healthcare Corporation
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.