Prescription drug
Where is Papaverine made?
4 companies sell it under their own name. Their labels name 2 factories in the United States.
United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| American Regent, Inc.30 mg per 1 mL · NDC 0517-4002 | American Regent, Inc.Makes it and tests it | Shirley, NY, United States | Problems found, fixed voluntarilyApr 2024 |
| BPI Labs, LLC30 mg per 1 mL · NDC 54288-142 | BPI Labs LLCMakes it and tests it | Largo, FL, United States | Problems found, fixed voluntarilyApr 2025 |
| Nexus Pharamaceuticals Inc.30 mg per 1 mL · NDC 14789-121 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Oryza Pharmaceuticals Inc.30 mg per 1 mL · NDC 72516-024 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jul 24, 2026 · Class I · American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde - Mar 14, 2022 · Class II · Vitae Enim Vitae Scientific, Inc.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.