D-0145-2025 Class II Terminated
FDA drug recall D-0145-2025 was initiated by Keystone Industries on November 14, 2024 and is designated Class II. 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 reject… The recall status is terminated (terminated April 23, 2026).
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2024
- Initiation Date
- November 14, 2024
- Termination Date
- April 23, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
Distribution Pattern
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Code Information
Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64119