REGULATORY INTELLIGENCE·Recall
FDA Class III Recall: Elevate Oral Care's Sodium Fluoride Product Pulled Due to Label Mix-Up
Elevate Oral Care has completed a Class III recall (D-0658-2024) of its Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor product. Initiated on August 20, 2024, the voluntary recall addressed a critical label mix-up affecting 120 direct customers nationwide. This event underscores the persistent risk of packaging errors in pharmaceutical supply chains, demanding robust quality control protocols from manufacturers and vigilant oversight from procurement teams.
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