Reported Dec 24, 2025 · Ongoing
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL,…
Novocol Pharmaceutical of Canada, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novocol Pharmaceutical of Canada, Inc. · 25 Wolseley Crt · Cambridge · N/A
Is this the product you have?
- 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
- Lot codes and dates
- LotD05004E
- expires04-30-2027
- Amount recalled
- 1,636 cartons
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Defective container: cracked/broken cartridges
This product could cause temporary or reversible health problems — stop using it.
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