Keystone Industries recalls Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Pro
Recalled December 25, 2024 · FDA recall D-0139-2025 · Keystone Industries
Hazard
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. · FDA Class II
Sold at
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Description
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Product
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
Manufacturer(s)
Keystone Industries
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →