safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL),… 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

safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only.

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