Phentolamine mesylate injection recalled over cracked and broken cartridges
Novocol Pharmaceutical of Canada is recalling 1,636 cartons of OraVerse (Phentolamine Mesylate) Injection over a defective container with cracked or broken cartridges.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites cracked or broken cartridges with no stated clinical consequence or reported harm.
Plain-English summary
OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in cartons containing 10 cartridges, made in Canada by Novocol Pharmaceutical of Canada, Inc. and distributed by Septodont, Inc. of Louisville, Colorado, is being recalled.
The reason given in the enforcement record is a defective container: cracked or broken cartridges.
The recall covers 1,636 cartons from lot D05004E, expiry 04-30-2027. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record describes a container defect and states no clinical consequence or reported injuries. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- ORAVERSE (PHENTOLAMINE MESYLATE)
- Brand
- ORAVERSE
- Manufacturer
- Novocol Pharmaceutical of Canada, Inc.
- Category
- Drug — Dental injectable
- Affected units
- 1,636
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: D05004E
- expires: 04-30-2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Novocol Pharmaceutical of Canada, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same brand · ORAVERSE
- LowSeptodont Recalls OraVerse Injection Due to Impurity Test Failure
FDA (Drugs) · 2018-05-16
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