FDAHealthOctober 31, 2025
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 Canada by Novocol Phar
⚠️ Defective container: cracked/broken cartridges
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 31, 2025
U.S.A. Nationwide
What's affected?
- 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
- Brand
- ORAVERSE
- Lot code
- D05004E
Additional details
Lot: D05004E, expires: 04-30-2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,636 cartons.
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