CanadaOraVerse solution (phentolamine mesylate 0.4 mg / 1.7 mL), Market Authorization DIN 02421666, lots D05004B and D05004D is affected. It was distributed to wholesalers who did not hold an establishment licence for sale in Canada. Verify if your product is one of the affected lots; consult your healthcare provider before discontinuing use or for health concerns, contact the recalling firm with questions, and report any side effects or other safety complaints to Health Canada.
What's being recalled
Depth of recall: Wholesalers
Companies: Recalling Firm:, Novocol Pharmaceutical of Canada Inc. (subsidiary of Septodont), 25 Wolseley Court, Cambridge, ON, Canada, N1R 6X3, Market Authorization Holder:, Septodont 58 Rue Du Pont De Creteil, St-Maur-Des-Fosses, Val-De-Marne, France, 94107.
How to identify it
Brand: OraVerse; Product Name: OraVerse; Market Authorization: DIN 02421666; Dosage Form: Solution; Strength: PHENTOLAMINE MESYLATE 0.4 MG / 1.7 ML; Lot: D05004B, D05004D
The hazard
Distribution of a prescription drug to wholesaler(s) who did not hold an establishment license.
What to do
Verify if your product is affected.
Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
Contact the recalling firm if you have any questions about the recall.
Report any health product related side effects to Health Canada.
Report any other health product safety complaints to Health Canada.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)