Recalls / Class II
Class IID-0137-2025
Product
Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.
- Brand name
- Gelato Topical Anesthetic
- Generic name
- Benzocaine
- Active ingredient
- Benzocaine
- Route
- Dental
- NDC
- 68400-352
- FDA application
- M022
- Affected lot / code info
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone item No. 03-02319
Why it was recalled
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.
Recalling firm
- Firm
- Keystone Industries
- Manufacturer
- Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 480 S Democrat Rd, Gibbstown, New Jersey 08027-1239
Distribution
- Distribution pattern
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Timeline
- Recall initiated
- 2024-11-14
- FDA classified
- 2024-12-13
- Posted by FDA
- 2024-12-25
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0137-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.