General Anesthetic
Where is Propofol made?
16 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 8 factories in India, Italy, Sweden, Austria and China.
India 4Italy 1Sweden 1Austria 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC Diprivan10 mg per 1 mL · NDC 63323-269 | Corden Pharma SpaMakes it, tests it, packages it and labels it | Caponago, Italy | Problems found, fixed voluntarilyMar 2025 |
| Fresenius Kabi ABMakes it, makes the active ingredient and tests it | Uppsala, Sweden | Problems found, fixed voluntarilyJan 2025 | |
| Fresenius Kabi AustriaMakes it, tests it and packages it | Austria 8055, Austria | Problems found, fixed voluntarilyMar 2024 | |
| Amneal Pharmaceuticals Private Limited10 mg per 1 mL · NDC 80830-1188, 80830-2364, 80830-2365 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | No problems foundAug 2024 |
| Anthea Pharma Private Limited10 mg per 1 mL · NDC 83854-018 | Anthea Pharma Private LimitedMakes it | Sangareddy, India | Not inspected on record |
| Baxter Healthcare Corporation10 mg per 1 mL · NDC 36000-058 | Baxter Pharmaceuticals India Private LimitedMakes it, tests it, packages it, labels it and sterilizes it | Ahmedabad, India | Serious problems, FDA actionJan 2023 |
| Dr. Reddy's Laboratories Inc.10 mg per 1 mL · NDC 43598-265, 43598-548, 43598-549 | Corden Pharma SpaMakes it and tests it | Caponago, Italy | Problems found, fixed voluntarilyMar 2025 |
| Fresenius Kabi USA, LLC Diprivan10 mg per 1 mL · NDC 65219-800 | Fresenius Kabi ABMakes it, makes the active ingredient and tests it | Uppsala, Sweden | Problems found, fixed voluntarilyJan 2025 |
| Hospira, Inc.10 mg per 1 mL · NDC 0409-4699, 0409-6010, 0409-1511 +2 | Pfizer Healthcare India Private LimitedMakes it, tests it, packages it and labels it | Anakapalli, India | Problems found, fixed voluntarilyOct 2022 |
| Meitheal Pharmaceuticals Inc.10 mg per 1 mL · NDC 71288-729, 71288-730, 71288-731 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Avenacy Inc.10 mg per 1 mL · NDC 83634-603 | The label doesn't name the factory. Plants this company names for other drugs | ||
| B. Braun Medical Inc.10 mg per 1 mL · NDC 0264-4850 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Civica, Inc.10 mg per 1 mL · NDC 72572-590, 72572-601, 72572-612 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.10 mg per 1 mL · NDC 23155-345 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.10 mg per 1 mL · NDC 0641-6194, 0641-6195, 0641-6196 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Northstar Rx LLC.10 mg per 1 mL · NDC 16714-528, 16714-977, 16714-690 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pfizer Laboratories Div Pfizer Inc10 mg per 1 mL · NDC 0069-0209, 0069-0234, 0069-0248 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals10 mg per 1 mL · NDC 25021-608 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Propofol 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.
- General Injectables & Vaccines, Inc.:
52584-269 - Genixus:
80700-113 - HF Acquisition Co. LLC. DBA HealthFirst:
51662-1293,51662-1470,51662-1471
Recalls
- Aug 22, 2022 · Class I · Pfizer Inc.
Presence of particulate matter - Jul 13, 2022 · Class I · Pfizer Inc.
Presence of particulate matter: particulate identified as a beetle. - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office · 2 recall notices
cGMP deviations: Temperature abuse - Dec 23, 2014 · Class II · Hospira Inc.
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron. - Oct 6, 2014 · Class I · Hospira Inc.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. - Apr 2, 2014 · Class I · Hospira Inc.
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solutio… - Dec 12, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become… - Oct 11, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection. - Aug 14, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection. - May 25, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel - Apr 8, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection. - Feb 25, 2013 · Class II · Hospira Inc.
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.