FDA WARNING_LETTER - Imprimis Pharmaceuticals

The FDA issued a Warning Letter to Imprimis Pharmaceuticals Inc. for misbranding several compounded drug products, including "Dropless," "LessDrops," "Simple Drops," and "Klarity C-Drops." The violations stem from false or misleading claims on the firm's website and promotional materials.

Specifically, Imprimis falsely represented that "Simple Drops" were made with FDA-approved components and that "Klarity C-Drops" were FDA-approved, when they are compounded using bulk drug substances not approved by the FDA. Furthermore, the promotional materials for "Dropless," "LessDrops," and "Simple Drops" omitted crucial risk information, including side effects, contraindications, and potential consequences of use, despite known risks associated with their active ingredients (e.g., hemorrhagic occlusive retinal vasculitis, elevated intraocular pressure, glaucoma).

The FDA also found misleading efficacy claims for "Simple Drops," suggesting a "One Simple Drop. One Simple Regimen" approach for elevated intraocular pressure. However, the active ingredients in these products often require multiple doses at different times for 24-hour effectiveness, a fact not disclosed, potentially leading to inadequate treatment and vision loss.

These violations misbrand the products under sections 201(g)(1), 201(n), 352(a), 352(bb), and 331(a) of the FD&C Act. Imprimis