Novocol Pharmaceutical of Canada, Inc.: Drug Recall
Recall #D-0234-2026 · 10/31/2025
Class II: Risk
Recall Details
- Recall Number
- D-0234-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Novocol Pharmaceutical of Canada, Inc.
- Status
- Ongoing
- Date Initiated
- 10/31/2025
- Location
- Cambridge, Canada
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,636 cartons
Reason for Recall
Defective container: cracked/broken cartridges
Product Description
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
Distribution Pattern
U.S.A. Nationwide
Other Recalls by Novocol Pharmaceutical of Canada, Inc.
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
View all recalls by Novocol Pharmaceutical of Canada, Inc. →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.