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Mericon Industries, Inc. was cited for manufacturing and distributing three unapproved new drugs—Florical 100 capsules, Florical 500 capsules, and Meribin 120 capsules—through their website with disease claims including "prevention and remediation of osteoporosis," which established these products as drugs under FDA law. The company failed to obtain FDA approval before marketing these products for therapeutic uses, violating the Federal Food, Drug, and Cosmetic Act. The violations were identified during an FDA inspection conducted August 12-21, 2024, at their Peoria, Illinois facility, and were confirmed through subsequent review of their website in February 2025.