FDAFDA · Food and drugs·Recall number D-0145-2025
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.
Published December 25, 2024 · Recall initiated: November 14, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL
- Manufacturer
- Keystone Industries
- Distributor
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Lot
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64119
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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