ivsupplyclinic.com – FDA Warning Letter, Mar 5, 2024

On February 9, 2024, the FDA issued a Warning Letter to www.ivsupplyclinic.com for introducing misbranded drugs into interstate commerce, violating sections 301(a), 301(k), and 503(b) of the FD&C Act. The website offers intravenous (IV) fluid drug products, including "Lactated Ringer’s and 5% Dextrose Injection USP," "0.9% Sodium Chloride Injection USP," and "5% Dextrose Injection USP," all manufactured by Baxter Healthcare Corporation. These are FDA-approved prescription drugs, intended for use under professional supervision.

The violations include selling these prescription drugs without requiring a prescription, which misbrands them under section 503(b)(1) and violates 301(k). Additionally, www.ivsupplyclinic.com altered product label images by removing the "RX ONLY" symbol and "BY A PHYSICIAN" dosing instructions, misbranding the drugs under section 503(b)(4) and violating 301(k). These actions also cause the introduction of misbranded drugs into interstate commerce, violating 301(a).

The FDA emphasizes the inherent risks of purchasing misbranded injectable drugs, including contamination, counterfeiting, and varying active ingredient amounts, which can lead to serious conditions like septicemia. The company is required to cease offering misbranded drugs for sale