Recalls / Class II
Class IID-0234-2026
Product
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
- Brand name
- Oraverse
- Generic name
- Phentolamine Mesylate
- Active ingredient
- Phentolamine Mesylate
- Route
- Submucosal
- NDC
- 0362-0101
- FDA application
- NDA022159
- Affected lot / code info
- Lot: D05004E, expires: 04-30-2027
Why it was recalled
Defective container: cracked/broken cartridges
Recalling firm
- Firm
- Novocol Pharmaceutical of Canada, Inc.
- Manufacturer
- Septodont, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25 Wolseley Crt, Cambridge, N/A, Canada
Distribution
- Quantity
- 1,636 cartons
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2025-10-31
- FDA classified
- 2025-12-12
- Posted by FDA
- 2025-12-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0234-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.