
The FDA has issued a warning letter to an Amazon seller for distributing unapproved eye products, including "Similasan Pink Eye Relief" and others. The products, categorized as new drugs, were purchased by the FDA through the seller's website, raising public health concerns. The agency emphasizes the products' lack of FDA approval, citing specific claims on labels as evidence of their drug classification. The seller is given fifteen working days to address and correct the violations, with legal action threatened for non-compliance. The FDA urges a prompt response outlining corrective measures.
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