Bell Pharmaceuticals, Inc — Class II: LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL
Bell Pharmaceuticals, Inc. has initiated a Class II recall for LEADER Carbamide Peroxide 6.5% ear drops due to the product being subpotent, exhibiting a low pH and an assay value of approximately 0.6% compared to the expected range of 6-7%.
This affects Bell Pharmaceuticals, Inc., the distributor Cardinal Health, and quality and compliance personnel responsible for OTC ear care products.
A significant reduction in active ingredient assay (approximately 10% of the expected concentration) suggests potential stability or formulation failures. For regulatory professionals, this underscores the importance of pH monitoring in peroxide-based solutions, as deviations can lead to rapid degradation of the active pharmaceutical ingredient.
Quality units should review stability data and pH specifications for carbamide peroxide formulations to ensure long-term potency. Regulatory and procurement teams managing Cardinal Health-distributed products should verify inventory against the specified NDC numbers (70000-0689-1 and 70000-0688-1).
Class II. Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).. Product: LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.. Firm: Bell Pharmaceuticals, Inc (Belle Plaine MN United States). Status: Ongoing.
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