Drug recall D-0145-2025
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.
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. Product was to be rejected but was inadvertently released and shipped to customers.
Lots and codes
Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64119
Recall details
- Recalling firm
- Keystone Industries, Gibbstown, NJ
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 14, 2024
- Terminated
- April 23, 2026
Related products
- Safco Sensicaine Ultra Topical Anesthetic Gel – drug information
- NDC 67239-0219 Safco Sensicaine Ultra Topical Anesthetic Gel · Benzocaine 200 mg/g · Safco Dental Supply Co.