Novocol Pharmaceutical of Canada, Inc. recalls OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL,
Recalled December 24, 2025 · FDA recall D-0234-2026 · Novocol Pharmaceutical of Canada
Hazard
Defective container: cracked/broken cartridges · FDA Class II
Units
1,636 cartons
Sold at
U.S.A. Nationwide
Description
Defective container: cracked/broken cartridges
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
Manufacturer(s)
Novocol Pharmaceutical of Canada, Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →