Owen Biosciences Inc. — Class II: FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT
Owen Biosciences Inc. has initiated a Class II recall for FHF Farmhouse Fresh Midnight Clearing Night Lotion, a 2.5% benzoyl peroxide OTC acne treatment, due to chemical contamination with benzene. The recall includes both 0.5 fl. oz. and 1 fl. oz. tube sizes and is currently listed as ongoing.
This recall affects Owen Biosciences Inc., FarmHouse Fresh, and practitioners or distributors involved in the supply chain of OTC benzoyl peroxide acne treatments. Operations, Quality, and Compliance departments are directly impacted.
The presence of benzene, a known contaminant, in a benzoyl peroxide-based product suggests potential stability or raw material integrity issues. For regulatory professionals, this underscores the continued FDA scrutiny regarding benzene contamination in topical OTC products. This Class II designation indicates that while the health hazard is not immediate or severe, the product does not meet regulatory standards for safety and purity.
Quality units should review testing protocols for benzene in products containing benzoyl peroxide. Regulatory teams should monitor the status of this ongoing recall to ensure all affected lots are accounted for and documented within the firm’s recall management system.
Class II. Reason: Chemical contamination: Presence of benzene. Product: FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas. Firm: Owen Biosciences Inc. (Baton Rouge LA United States). Status: Ongoing.
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