CanadaThe recall affects Septodont products distributed by Novocol Pharmaceutical of Canada Inc.: Cook‑Waite Lidocaine 2% and Epinephrine 1:100,000 (DIN 02473518), lot D05407A; 3% POLOCAINE DENTAL (DIN 02330733), lot D05159E; and OraVerse (DIN 02421666), lot D05004F, identifiable by brand, DIN and lot number. They were recalled because glass cartridges may be cracked. Verify if your product is affected, consult your healthcare provider before stopping use, contact the recalling firm with questions, and report any side effects or safety complaints to Health Canada.
What's being recalled
Depth of recall: Wholesalers, Health Care Establishments
Companies: Novocol Pharmaceutical of Canada Inc. (subsidiary of Septodont), 25 Wolseley Court, Cambridge, ON, Canada, N1R 6X3.
How to identify it
Brand: Cook-Waite Lidocaine 2% and Epinephrine 1:100,000; Product Name: LIDOCAINE 2% AND EPINEPHRINE 1:100,000; Market Authorization: DIN 02473518; Dosage Form: Solution; Strength: LIDOCAINE HYDROCHLORIDE 20 MG / ML, EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.01 MG / ML; Lot: D05407A
Brand: 3% POLOCAINE DENTAL; Product Name: 3% POLOCAINE DENTAL; Market Authorization: DIN 02330733; Dosage Form: Liquid; Strength: MEPIVACAINE HYDROCHLORIDE 30 MG / ML; Lot: D05159E
Brand: OraVerse; Product Name: OraVerse; Market Authorization: DIN 02421666; Dosage Form: Solution; Strength: PHENTOLAMINE MESYLATE 0.4 MG / 1.7 ML; Lot: D05004F
The hazard
Glass cartridges may be cracked in the affected lot(s).
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)