Polocaine dental cartridges recalled over cracked and broken containers
Novocol Pharmaceutical of Canada is recalling 5,825 units of 3% Polocaine Dental mepivacaine 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
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCl Injection, USP), packaged in cartons containing 50 single-dose cartridges of 1.7 ml each, manufactured for Dentsply Pharmaceutical of York, Pennsylvania by Novocol Pharmaceutical of Canada, Inc., is being recalled.
The reason given in the enforcement record is a defective container: cracked or broken cartridges.
The recall covers 5,825 units from lot D05159C, expiry 07-31-2027. 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
- POLOCAINE (MEPIVACAINE HYDROCHLORIDE)
- Brand
- POLOCAINE
- Manufacturer
- Novocol Pharmaceutical of Canada, Inc.
- Category
- Drug — Dental injectable
- Affected units
- 5,825
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: D05159C
- expires: 07-31-2027
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.
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