Official recall notice
FDA DrugClass IINotable
FDA Recall: Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl.
- Recall date
- 2026-07-22
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Product description
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Affected products
Lot: a) 1504241, exp 2027-03; b) 1504291, 1504301, exp 2027-03.