Polymyxin-class Antibacterial
Where is Colistimethate made?
5 companies sell it under their own name. Their labels name 1 factory in the United States.
United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC150 mg per 2 mL · NDC 63323-393 | Fresenius Kabi USA, LLCMakes it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| ENDO USA, Inc. Coly-MycinM150 mg per 2 mL · NDC 42023-107 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.150 mg per 4 mL · NDC 23155-193 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.150 mg · NDC 0143-9443 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Xellia Pharmaceuticals USA LLC150 mg · NDC 70594-023 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Feb 25, 2015 · Class II · Heritage Pharmaceuticals, Inc.
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.