alpha-Adrenergic Blocker
Where is Phentolamine made?
4 companies sell it under their own name. Their labels name 2 factories in Italy and Canada.
Italy 1Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Precision Dose Inc.5 mg · NDC 68094-101 | NerPharMa S.r.lMakes it | Nerviano, Italy | Problems found, fixed voluntarilySep 2024 |
| Septodont, Inc. Oraverse0.235 mg per 1 mL · NDC 0362-0101 | Novocol Pharmaceutical of Canada, Inc.Makes it | Cambridge, Canada | Problems found, fixed voluntarilyMay 2024 |
| Hikma Pharmaceuticals USA Inc.5 mg per 1 mL · NDC 0143-9564 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Oyster Point Pharma, Inc. Ryzumvi10 mg per 1 mL · NDC 83368-075 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Oct 31, 2025 · Class II · Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges - Apr 13, 2018 · Class III · Septodont Inc.
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.