Copaliner Cavity Varnish Recalled for Solvent Mislabeling Error
Keystone Industries recalls Copaliner Cavity Varnish after discovering bottles of Copaliner Solvent were accidentally packaged in boxes labeled as varnish. The error affected 337 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a packaging and labeling error in which solvent was placed in boxes labeled as cavity varnish. No illnesses or injuries have been reported. The FDA Class II classification, without evidence of reported harm, falls under 'minor labeling errors' per the severity rubric.
Plain-English summary
Keystone Industries is recalling Copaliner Cavity Varnish .5oz (14 ml) due to a packaging error. Bottles of Copaliner Solvent were inadvertently packaged in boxes labeled as Copaliner Varnish (Item No. 0921526) and distributed as such.
The recalled product consists of 337 units with Lot No. NB7972 (UDI: *+H66809215261/$$3241027NB7972%*) that were distributed worldwide in the United States, Canada, Bangladesh, Germany, and the United Kingdom. The varnish is intended to provide a marginal seal between the dentin and amalgam in dental procedures.
The recalled product
- Product
- Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526
- Manufacturer
- Keystone Industries
- Hazard
- Affected units
- 337
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972
Distribution
Distributed nationwide across the United States.
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