Class IIReported 2025-12-24

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.

Reason for Recall

Defective container: cracked/broken cartridges

Recall Number

D-0234-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-10-31

Reported

2025-12-24

Distribution

U.S.A. Nationwide

Code Info

Lot: D05004E, expires: 04-30-2027

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.