PillPhentolamine Mesylate
Brands: Oraverse · Phentolamine Mesylate
1 active makers
soon
soon
soon
soon
Medicaid dispensing volume
No Medicaid utilization on record for this drug concept yet. Quarterly volume (CMS State Drug Utilization Data) loads with the utilization ETL.
Who makes it1 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Septodont, Inc. | unknown | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Oct 31, 2025RECALLRecall (Class II): OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL,…
Defective container: cracked/broken cartridges — Recalling firm: Novocol Pharmaceutical of Canada, Inc. — U.S.A. Nationwide
- Apr 13, 2018RECALLRecall (Class III): OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx o…
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. — Recalling firm: Septodont Inc. — USA, Italy and France