Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Novocol Pharmaceutical of Canada, Inc. | Cambridge, Canada | Makes it | Problems found, fixed voluntarilyMay 3, 2024 · 11 inspections |
Recalls
- Oct 31, 2025 · Class II · Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
Lots: Lot: D05004E, expires: 04-30-2027 - 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.
Lots: Lot #'s D01894E and D01894G
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Phentolamine: every company that makes it
- Form
- injection, solution, submucosal
- Strength
- 0.235 mg per 1 mL
- Approval
- NDA NDA022159
- On the market since
- Jun 1, 2011
- Package NDCs
0362-0101-10- Official label
- DailyMed (National Library of Medicine), updated Dec 5, 2018
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