Polymyxin-class Antibacterial
Where is Polymyxin B made?
8 companies sell it under their own name. Their labels name 3 factories in India and the United States.
India 2United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC500000 [USP'U] · NDC 63323-321, 63323-367 | Fresenius Kabi USA, LLCMakes it and tests it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 | |
| AuroMedics Pharma LLC500000 [USP'U] · NDC 55150-234 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Gland Pharma Limited500000 [USP'U] · NDC 68083-174 | Gland Pharma LimitedMakes it, tests it, packages it and labels it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Xellia Pharmaceuticals, ApS500000 1 · NDC 45932-0030 | Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Fosun Pharma USA Inc.500000 [USP'U] · NDC 72266-249 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.500000 [USP'U], 500000 [iU] · NDC 0143-9461, 0143-9941 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sagent Pharmaceuticals500000 [USP'U] · NDC 25021-196 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Xellia Pharmaceuticals USA LLC500000 [USP'U] · NDC 70594-049 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jan 26, 2022 · Class I · AuroMedics Pharma LLC
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.