Keystone Industries Initiates Class II Recall for Gelato Benzocaine Gel Due to CGMP Deviations
Keystone Industries has executed a Class II recall (D-0137-2025) for its Gelato Benzocaine 20% Topical Gel Anesthetic. This action stems from critical CGMP deviations where a quality-rejected batch was inadvertently released and shipped. This event underscores significant supply chain risks for distributors and healthcare providers across the USA, Canada, and Latin American markets.
FDA Class II Recall: Keystone Industries' CGMP Deviations for Benzocaine Gel
Keystone Industries, operating as Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc, initiated a Class II recall (D-0137-2025) on November 14, 2024, for its Gelato, Benzocaine 20% Topical Gel Anesthetic Gel. This critical regulatory action was prompted by significant Current Good Manufacturing Practice (CGMP) deviations at its Gibbstown, NJ facility. Specifically, a routine inspection by the Quality Unit identified scratches on the sides and bottom of a mixing vessel used for the bulk product. Following this discovery, the bulk product, identified by Lot: BNZ-001646 with an expiration date of November 26, 2026, was appropriately rejected by the Quality Unit. However, a severe lapse in quality control protocols led to this rejected product being inadvertently released and subsequently shipped to customers. For procurement directors and supply chain VPs, this incident highlights a profound failure in quality assurance and product release mechanisms, directly impacting product integrity and patient safety. The inadvertent release of a known non-conforming product exposes downstream partners to significant reputational and regulatory risks, necessitating an immediate review of supplier qualification and auditing processes for all critical pharmaceutical inputs.
Affected Product and Global Distribution Footprint of Gelato Topical Anesthetic
The recalled product is Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), with NDC# 68400-352-30. This human OTC drug, designed for dental application, is a widely used topical anesthetic containing Benzocaine. The distribution pattern for the affected lot (BNZ-001646) was extensive, reaching customers nationwide across the United States and Canada, as well as internationally in the Dominican Republic, El Salvador, Honduras, and Qatar. For business development executives and regulatory affairs heads, this broad distribution footprint means that the recall has significant international implications, requiring coordinated efforts across multiple jurisdictions. Companies involved in distributing or utilizing this specific Benzocaine product in these regions must immediately assess their inventory, quarantine affected stock, and comply with all local regulatory requirements for product retrieval and disposition. The widespread impact underscores the interconnectedness of global supply chains and the ripple effect of quality control failures at a single manufacturing point.
Supply Chain Exposure: Immediate Impact on Distributors and Healthcare Providers
The Class II recall of Keystone Industries' Gelato Benzocaine 20% Topical Gel Anesthetic Gel presents immediate and tangible supply chain exposure for distributors, dental practices, and healthcare providers across North America, the Caribbean, Central America, and the Middle East. Entities in the USA, Canada, Dominican Republic, El Salvador, Honduras, and Qatar that have procured Lot: BNZ-001646 (Exp Date: 11/26/2026) are directly impacted. Procurement directors must urgently identify the volume of affected product within their supply chains and initiate recall procedures, including customer notification and product return. The disruption to the supply of a commonly used dental anesthetic can lead to operational challenges for dental clinics and potentially impact patient care if alternative supplies are not rapidly secured. Regulatory affairs teams must ensure strict adherence to FDA guidelines for recall management, mitigating potential legal and compliance risks associated with distributing or using a compromised product. This event underscores the necessity for robust traceability systems and rapid response protocols within pharmaceutical distribution networks.
Alternative Sourcing Strategies for Benzocaine Topical Anesthetics
The ChemLifeIntel Knowledge Graph does not currently identify specific alternative suppliers for Benzocaine 20% Topical Gel Anesthetic Gel beyond Keystone Industries. This absence of readily available alternative supplier data within our intelligence framework suggests that the market for this specific formulation may be concentrated or that proprietary aspects limit direct substitutes. For procurement directors, this situation necessitates an immediate and comprehensive internal assessment to identify and qualify alternative manufacturers of Benzocaine topical anesthetics. This process should prioritize suppliers with a proven track record of CGMP compliance, robust quality management systems, and sufficient production capacity to meet demand. Evaluating potential alternatives will involve stringent due diligence, including facility audits, review of regulatory history, and assessment of lead times for qualification and supply. The lack of pre-vetted alternatives increases the urgency and complexity of mitigating supply chain risk, potentially leading to higher sourcing costs or temporary supply gaps while new suppliers are brought online.
Keystone Industries' Regulatory Compliance Record and Future Implications
The ChemLifeIntel Knowledge Graph does not contain prior regulatory actions or a historical compliance record for Keystone Industries. This Class II recall, therefore, serves as the primary recent data point for assessing the company's regulatory risk profile. While the recall was voluntarily initiated by Keystone Industries, the underlying cause—the inadvertent release of a quality-rejected batch due to CGMP deviations—represents a significant lapse in fundamental quality control. For regulatory affairs heads, this incident signals a need for heightened scrutiny of Keystone Industries' quality systems. The firm's ability to implement effective corrective and preventive actions (CAPA) will be critical in restoring confidence. The recall was initiated on November 14, 2024, and officially terminated on April 23, 2026, indicating a prolonged period for product retrieval and resolution across its extensive distribution network. This lengthy termination timeline suggests the complexity and scope of the recall, implying a substantial undertaking by Keystone Industries to address the issue and ensure affected product removal. Supply chain VPs should seek detailed assurances regarding the robustness of these CAPA measures and consider enhanced auditing protocols for future engagements.
Remediation Timeline and Post-Recall Business Continuity Considerations
Keystone Industries initiated the voluntary Class II recall (D-0137-2025) for its Gelato Benzocaine 20% Topical Gel Anesthetic Gel on November 14, 2024. The FDA classified this action as Class II, indicating that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The recall was officially terminated on April 23, 2026, signifying that Keystone Industries has completed the necessary actions to remove the affected Lot: BNZ-001646 from the market and addressed the immediate risk. For business development executives and procurement directors, the termination of the recall provides a degree of clarity regarding product availability. However, the underlying CGMP failure—the inadvertent release of rejected product—demands a thorough understanding of the corrective actions implemented by Keystone Industries. Partners should request detailed information on how the company has strengthened its Quality Unit's oversight, improved mixing vessel maintenance protocols, and reinforced product release procedures to prevent recurrence. Proactive engagement with Keystone Industries on these remediation efforts is crucial for assessing ongoing supply reliability and mitigating future compliance risks, ensuring long-term business continuity.