Keystone Industries — Class II: DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured
Keystone Industries has initiated a Class II recall for DHP Topical Anesthetic Gel (Benzocaine 20%, Strawberry Flavor) due to defective containers that may have incomplete seals. This recall affects the 1 oz. (30 g) units distributed under NDC 69634-020-30.
This affects Keystone Industries, Dental Health Products, Inc., and dental professionals or organizations using this specific strawberry-flavored topical anesthetic gel. Operational functions involved include packaging, quality control, and distribution.
An incomplete seal on a pharmaceutical container compromises product integrity and may lead to contamination or loss of efficacy. This Class II designation suggests that while the health hazard is not immediate or severe, the defect represents a failure in manufacturing quality controls or packaging validation. Quality teams may see this as a signal to audit supplier quality for container components or primary packaging line performance.
QA and packaging teams should review container closure integrity testing (CCIT) protocols for topical gels. Regulatory departments should verify that existing inventory of NDC 69634-020-30 is identified and handled according to standard operating procedures for ongoing Class II recalls.
Class II. Reason: Defective container:may contain bottles with incomplete seals. Product: DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30. Firm: Keystone Industries (Gibbstown NJ United States). Status: Ongoing.
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