sandra-pharma.is – FDA Warning Letter, Jan 5, 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
ID · 1d0f2df5-b72c-46cc-b1ef-b15c26db05f2
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.