FDA recall Z-2579-2023

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

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.

Key facts

Status

Ongoing

Initiation date

2023-07-21

Report date

2023-09-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gibbstown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2579-2023