Bell Pharmaceuticals, Inc — Class II: QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (
Bell Pharmaceuticals, Inc. has initiated a Class II recall for Carbamide Peroxide 6.5% due to subpotency. Testing revealed significantly reduced assay levels (approximately 0.6% compared to the expected 6.5%) and low pH levels.
This recall affects Bell Pharmaceuticals, Inc., the distributor C.D.M.A., Inc., and quality control teams responsible for stability monitoring and potency assays of carbamide peroxide products.
A significant assay reduction (down to ~10% of the target concentration) suggests a major stability failure or manufacturing deviation. Regulatory teams should note the Class II classification, which implies that while the risk of serious adverse health consequences is low, the product fails to meet its labeled efficacy standards. The simultaneous drop in pH and potency may indicate a chemical degradation pathway that necessitates a review of formulation stability or container-closure integrity.
Evaluate stability testing programs to ensure adequate detection of pH shifts and active ingredient degradation. Review batch release data for NDCs 63868-026-15 and 63868-027-16 to confirm no subpotent lots remain in distribution.
Class II. Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).. Product: QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.. Firm: Bell Pharmaceuticals, Inc (Belle Plaine MN United States). Status: Ongoing.
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