Class IIReported 2024-12-25
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.
Recalled by Keystone Industries
Reason for Recall
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
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Product was to be rejected but was inadvertently released and shipped to customers.