FDA recall D-0234-2026

Novocol Pharmaceutical of Canada, Inc. · Class II · drug

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

Distribution

U.S.A. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-10-31
Report date: 2025-12-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0234-2026