drugs Class II Updated 2024-12-25

Keystone Industries recalls safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64119
View official government recall

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