FDA-Drug2025-12-24Class II
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
Novocol Pharmaceutical of Canada, Inc.
Hazard
Defective container: cracked/broken cartridges
Sold states
U.S.A. Nationwide
Affected count
1,636 cartons
Manufactured in
25 Wolseley Crt, Cambridge, Canada
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0234-2026Don't want to check this manually?
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