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
Reported: December 24, 2025 Initiated: October 31, 2025 #D-0234-2026
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
Reason for Recall
Defective container: cracked/broken cartridges
Details
- Recalling Firm
- Novocol Pharmaceutical of Canada, Inc.
- Units Affected
- 1,636 cartons
- Distribution
- U.S.A. Nationwide
- Location
- Cambridge
Frequently Asked Questions
What product 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. Recalled by Novocol Pharmaceutical of Canada, Inc.. Units affected: 1,636 cartons.
Why was this product recalled? ▼
Defective container: cracked/broken cartridges
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 24, 2025. Severity: Moderate. Recall number: D-0234-2026.
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