Keystone Industries — Class II: PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufac
Keystone Industries has initiated a Class II recall for PureLife 20% Benzocaine Topical Anesthetic Gel (Strawberry Flavor, 1 oz bottles) due to defective containers that may have incomplete seals. Proprietary NDC 68987-001-30 is affected and the recall status is currently ongoing.
This recall affects Keystone Industries, PureLife LLC, and downstream distributors or dental professionals utilizing this specific 20% benzocaine topical gel product.
Incomplete container seals pose risks to product integrity, potentially leading to leakage, evaporation, or loss of potency. For a topical anesthetic, compromised packaging may also raise concerns regarding microbial contamination or oxidation of the active ingredient, necessitating a review of primary packaging quality control processes.
Quality units should review sealing validation protocols and visual inspection criteria for bottled topical products. Regulatory teams should ensure that NDC-specific distribution records are current to facilitate targeted product recovery if necessary.
Class II. Reason: Defective container:may contain bottles with incomplete seals. Product: PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30. Firm: Keystone Industries (Gibbstown NJ United States). Status: Ongoing.
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