Drug 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.
D-0145-2025
Product summary
- Event
- Event 95854
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0145-2025
Official wording
Reason: 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.
Code information: Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64119
Distribution pattern: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Derived failure modes
-
Manufacturing or process control
CGMP deviations