CLASS III Drug recall · Reported 16 May 2018 · FDA Enforcement Report
OraVerse (Phentolamine Mesylate) Injection, 0.4 mg recalled by Septodont
Septodont is recalling OraVerse (Phentolamine Mesylate) Injection, 0.4 mg. The recall was initiated on 13 Apr 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0828-2018
- FDA event ID
- 79976
- Recalling firm
- Septodont, Louisville, CO
- Brand
- Oraverse
- Manufacturer
- Septodont, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Apr 2018
- FDA classified
- 22 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Apr 2018 | Recall initiated by company | |
| 16 May 2018 | Published in enforcement report | +33 days |
| 22 May 2018 | Classified by FDA | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10
Where it was distributed
USA, Italy and France
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #'s D01894E and D01894G
Where was it sold?
USA, Italy and France
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Septodont
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Articaine Dental, Articane hydrochloride recalled by SeptodontArticadent | Septodont | Labeling Errors | Nationwide |
Other Phentolamine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg recalledOraverse | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | Phentolamine 10MG/ML Injection, 10MG/ML Solution vial recalled | Pharmacy Plus | Sterility | 4 states |
| Drug | CLASS II | Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg recalled | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Phentolamine mesylate 5 mg/35 mg/mannitol trituration recalled | Martin Avenue Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Phentolamine 20 mg/ml Injection recalled by Lowlite Investments | Lowlite Investments | Sterility | Nationwide |