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
Reason for recall: Defective container: cracked/broken cartridges
Recall initiated: 20251031
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated