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Covalent Medical was cited for marketing FOCUS PI Post-Injection Eye Drops as an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act, with the product sold over-the-counter through their website and social media platforms without FDA approval. The company made drug claims in product labeling, website content, and social media posts indicating the product was intended to diagnose, treat, or mitigate disease and/or affect bodily function, specifically referencing post-injection relief and lubrication benefits. The product was additionally found to be misbranded under section 502(ee) of the FD&C Act. The FDA's inspection occurred on September 27, 2024, identifying these violations across the company's e-commerce and social media distribution channels.