Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
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