AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
Reason
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Classification
Class II
Status
Ongoing
Lot
Lot: a)1505123, expires: 2027-04; b) 1505131, expires: 2027-04.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Bell Pharmaceuticals, Inc — Class II Recall | MedicineWatch US