FDA WARNING_LETTER - sandra-pharma.is - January 05, 2021

On January 28, 2021, the FDA issued a Warning Letter to www.sandra-pharma.is following a website review on January 5, 2021. The FDA observed the website offering drug products for sale in the U.S. that claim to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases like "infections."

The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], and misbranded drugs under section 502 of the FD&C Act [21 U.S.C. § 352]. The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act [21 U.S.C. § 331(a) and (d)].

Specifically, the website offered "Plaquinol 400mg" (hydroxychloroquine) and "Azitromicina Aurovitas 500mg" (azithromycin) as "COVID 19 Treatment 10+3 Tabs," claiming they "cure Covid 19 patients." While FDA-approved versions of these drugs exist, the products offered by sandra-pharma.is lack FDA approval and