Bell Pharmaceuticals, Inc — Class II: Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%
Bell Pharmaceuticals, Inc. has initiated a Class II recall for Clinere Carbamide Peroxide 6.5% due to the product being subpotent with a low pH and a significantly reduced assay of approximately 0.6% compared to the expected 6.5%.
This recall affects Bell Pharmaceuticals, Inc., Quest Products LLC as the distributor, and stakeholders involved in the manufacturing, quality oversight, and distribution of carbamide peroxide earwax removal products.
The significant deviation in assay—measured at nearly one-tenth of the labeled concentration—indicates a potential failure in formulation stability or manufacturing process controls. Regulatory departments should note that a Class II designation suggests that while the defect may cause temporary or medically reversible adverse health consequences, the probability of serious harm is remote; however, the lack of efficacy due to subpotency remains a compliance failure.
Quality units should review stability testing data and retention sample analysis for carbamide peroxide formulations to ensure pH and assay values remain within specification throughout the shelf life. Verification of raw material sourcing and manufacturing process controls regarding pH stabilization may be warranted.
Class II. Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).. Product: Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.. Firm: Bell Pharmaceuticals, Inc (Belle Plaine MN United States). Status: Ongoing.
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