Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
OraVerse (Phentolamine Mesylate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective container: cracked/broken cartridges
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10
Affected NDC
0362-0101-10
Compare with the code on your package — it is the most precise check available.
Drug: Phentolamine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Oraverse Phentolamine Mesylate NDC 00362-0101 |
.235 mg/mL | Injection, Solution Submucosal |
Septodont, Inc. | Rx |
- Recalling firm
- Novocol Pharmaceutical of Canada, Inc.
- NDC code
- 0362-0101-10
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0234-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Phentolamine recalls
See all
Class II · Moderate risk
BiMix STD 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 002
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix Injection
Lack of Assurance of Sterility
Other recalls by Novocol Pharmaceutical of Canada, Inc.
All 2025 recalls
Class II · Moderate risk
Cook-Walte
Defective container: cracked/broken cartridges
Class II · Moderate risk
Benco dental Graham CHEMICAL CO.
Defective container: cracked/broken cartridges
Class II · Moderate risk
darby dental supply
Defective container: cracked/broken cartridges
Class II · Moderate risk
3% Polocaine DENTAL
Defective container: cracked/broken cartridges
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.