FDAFDA · Food and drugs·Recall number D-0234-2026
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
Published December 24, 2025 · Recall initiated: October 31, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective container: cracked/broken cartridges
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ORAVERSE
- Manufacturer
- Novocol Pharmaceutical of Canada, Inc.
- Distributor
- U.S.A. Nationwide
- Lot
- Lot: D05004E, expires: 04-30-2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
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