Primo recalled over manufacturing violations

Recall date

November 14, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Keystone Industries recalls Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Pr…

Recall number

D-0139-2025

FDA classification

Class II

Brand / firm

Keystone Industries

Sold / distributed

Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.