BENZOCAINE Recall D-0137-2025
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.
BENZOCAINE Recall D-0137-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0137-2025 |
| Event ID | 95854 |
| Brand | GELATO TOPICAL ANESTHETIC |
| Generic Name | BENZOCAINE |
| Manufacturer | BENZOCAINE |
| Original Package? | 1 |
| Active Substance | BENZOCAINE |
| Drug Route | DENTAL |
| Distribution | Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar. |
| Recall 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. |
| Drug Classification | Class II |
| Drug Code Info | 20241225 |
| Product NDC | 68400-352 |
| Product NUI | N0000185508 N0000175629 N0000184306 |
| Pharma Class (PE) | Increased Histamine Release [PE] |
| Pharma Class (EPC) | Standardized Chemical Allergen [EPC] |
| Pharma Class (CS) | Allergens [CS] |
| Recall Initiation Date | 20241114 |
| Report Date | 20241225 |
| Classification Date | 20241213 |
| Address | 480 S Democrat Rd Gibbstown, NJ 08027-1239 United States |
| Recalling Firm | Keystone Industries |
| Initial Notification | |
| Unique Ingredient Identifier | U3RSY48JW5 |
| Drug Application Number | M022 |
| Structured Product Labeling (SPL ID) | 0bf1220f-a6ad-8a62-e063-6394a90af47e |
| Structured Product Labeling (SPL Set ID) | 1f8431bb-f33c-4fd8-9472-9b59ffb5f18e |
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