Opioid Agonist/Antagonist
Where is Butorphanol made?
5 companies sell it under their own name and 1 repackager rebottle it. Their labels name 4 factories in the United States and Portugal.
United States 3Portugal 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.1 mg per 1 mL, 2 mg per 1 mL · NDC 0143-9864, 0143-9867 | Hikma Farmaceutica (portugal), S.aMakes it, tests it, packages it and labels it | Terrugem Sintra, Portugal | Problems found, fixed voluntarilyApr 2023 |
| Hikma Pharmaceuticals USA Inc.10 mg per 1 mL · NDC 0054-3090 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Hospira, Inc.1 mg per 1 mL, 2 mg per 1 mL · NDC 0409-1623, 0409-1626 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Praxis, LLC10 mg per 1 mL · NDC 59368-400 | Sixarp, LLCMakes it, packages it and labels it | Grand Rapids, MI, United States | No problems foundMar 2025 |
| Apotex Corp.10 mg per 1 mL · NDC 60505-0813 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Butorphanol 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.
- Bryant Ranch Prepack:
72162-2099
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.