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.

Recall Number: D-0680-2026

Firm: Bell Pharmaceuticals, Inc

Classification: Class II

Status: Ongoing

Report Date: 20260722

Initiation Date: 20260625

Termination Date:

SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

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.