FDAClass IISeptember 20, 2023

Keystone Bosworth Copaliner Cavity Varnish .5oz recall

Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect…

Why was Keystone Bosworth Copaliner Cavity Varnish .5oz recalled?

A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972

Product
Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect…
Recalling firm
Keystone Industries
Quantity
337 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.
Recall date
September 20, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls