FDA DrugClass IINotable
FDA Recall: LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS,
Description
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Hazard
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Remedy
5, 471 units
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