Bell Pharmaceuticals, Inc — Class II: FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (
Bell Pharmaceuticals, Inc. has initiated a Class II recall for Family Wellness Carbamide Peroxide 6.5% ear kits (NDC 55319-835-01) due to sub-potency issues, including low pH and a significantly reduced assay of approximately 0.6% against an expected 6.5%.
This recall affects Bell Pharmaceuticals, Inc., Midwood Brands LLC (the distributor), and quality control, manufacturing, and distribution functions involved in the production and sale of carbamide peroxide kits.
The significant discrepancy between the observed assay (0.6%) and the labeled potency (6.5%) suggests a potential stability failure or significant manufacturing deviation. For regulatory professionals, this underscores the importance of monitoring pH as a potential indicator of active ingredient degradation or formulation instability, which can render the product clinically ineffective for earwax removal.
QA/QC teams should review stability testing protocols and retain sample data for oto-topical solutions to ensure pH and potency remain within specification throughout the product lifecycle. Distribution partners should verify current inventory against the identified NDC to facilitate the recall process and prevent further dispensing of sub-potent units.
Class II. Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).. Product: FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.. Firm: Bell Pharmaceuticals, Inc (Belle Plaine MN United States). Status: Ongoing.
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