Gelato Topical Anesthetic Gel
FDA Recall NDC 68400-352
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Gelato Topical Anesthetic (NDC 68400-352). A significant event, classified as Class II, was initiated on Nov 14, 2024 by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Nov 14, 2024
Dec 25, 2024
N/A
Recall Profile & Regulatory Data
Event ID
95854
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Keystone Industries
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Termination Date
Apr 23, 2026
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone item No. 03-02319
Affected Packages Involved in this Recall
68400-352-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
