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Novocol Pharmaceutical of Canada, Inc.: 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 Can

DrugsSource: FDA (drug) · Date: 2025-12-24

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Novocol Pharmaceutical of Canada, Inc.
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
Reason / hazard
Defective container: cracked/broken cartridges
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S.A. Nationwide
Recall initiated
2025-10-31
Code info
Lot: D05004E, expires: 04-30-2027
Product quantity
1,636 cartons
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
Country
Canada
Event id
98080
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