Warning
Novocol Pharmaceutical of Canada Recalls OraVerse
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0234-2026Drug / Pharmaceutical
Novocol Pharmaceutical of Canada Recalls OraVerse
Novocol Pharmaceutical of Canada, Inc. · Class II — Moderate Risk
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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S.A. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Novocol Pharmaceutical of Canada, Inc. has recalled a pharmaceutical product that the FDA classified as Class II affecting 1,636 cartons. The recall was initiated on October 31, 2025. Defective container: cracked/broken cartridges. It was distributed in U.S.A. Nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.