Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manu… recall

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.

Details

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.

Recalling company

Keystone Industries

Classification

Class II

Status

Terminated

Type

Voluntary: Firm initiated

Distribution

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

Initiated

Nov 14, 2024

FDA report date

Dec 25, 2024