Benco mepivacaine cartridges recalled over cracked and broken containers
Novocol Pharmaceutical of Canada is recalling Mepivacaine HCl 3% injection distributed by Benco Dental 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
Mepivacaine HCl 3% (30 mg/mL) Injection (Mepivacaine HCl Injection, USP), packaged in cartons containing 50 single-dose cartridges of 1.7 mL each, distributed by Benco Dental of Pittston, Pennsylvania, is being recalled.
The reason given in the enforcement record is a defective container: cracked or broken cartridges.
The recall covers lot D05159H, expiry 07-31-2027. The record does not state a quantity. 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
- MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE)
- Brand
- MEPIVACAINE
- Manufacturer
- Novocol Pharmaceutical of Canada, Inc.
- Category
- Drug — Dental injectable
- Hazard
- defective-container
- cracked-cartridge
- packaging
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: D05159H
- expires: 07-31-2027
Distribution
Distributed nationwide across the United States.
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