Infectious Disease
The FDA warns the website to stop illegal sales of unapproved false-branded hydroxychloroquine
April 28, 2021
3 min read
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The FDA issued a warning letter to an online pharmacy for allegedly selling unapproved and mislabeled drugs, including hydroxychloroquine and chloroquine, to treat COVID-19, lupus, rheumatoid arthritis, and other diseases.
According to the FDA, the pharmacygeoff.md website offers mislabeled versions of the drugs plaquenil (hydroxychloroquine sulfate, Sanofi), chloroquine, lopinavir / ritonavir (Kaletra, Abbott), ribavirin, and dexamethasone. 19 as well as a variety of other conditions. Products offered for sale on the website are also unapproved new drugs, according to the FDA, as they are not generally recognized as safe and effective for their labeled uses.
The FDA has issued a warning letter to an online pharmacy allegedly selling unapproved and mislabeled drugs such as hydroxychloroquine and chloroquine used to treat COVID-19, lupus, rheumatoid arthritis, and other diseases. Source: Adobe Stock
“The FDA is taking this action against www.pharmacygeoff.md because of the inherent risk to consumers buying bogus and unapproved new drugs,” stated the warning letter dated April 15, 2021, signed by Donald D. Ashley, Director of the Office of Compliance at the FDA Center for Drug Evaluation and Research.
“You should take immediate action to correct any violations of the law [Federal Food, Drug, and Cosmetic (FD&C) Act] (This may include offering similar bogus and / or unauthorized new drugs with the exception of the drugs listed above), ”adds the letter. “We encourage you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleading your products as being safe and effective for use for which they have not been approved by the FDA and that you are not Assert claims that mislabeled the products in violation of the FD&C law. “
The letter follows a review of the website by the FDA on March 22nd. The government found that several unapproved and mislabeled prescription drugs were allegedly offered for sale directly to consumers.
Among these drugs was a product called “Plaquenil (hydroxychloroquine sulfate)”. According to the FDA, the website pharmacygeoff.md claims that this product “has recently been used to treat patients with COVID-19,” in addition to inflammatory diseases and malaria.
“While there are FDA approved versions of hydroxychloroquine, including ‘Plaquenil’ on the market in the US, there are no approved drug uses … for the ‘Plaquenil (hydroxychloroquine sulfate)’ made by Sanofi and sold by www. Pharmacygeoff. md “, says the warning letter. “FDA-approved hydroxychloroquine is labeled for the treatment of uncomplicated malaria, discoid and systemic lupus erythematosus, and acute and chronic rheumatoid arthritis and is only available by prescription. In addition, hydroxychloroquine has not been approved by the FDA for the prevention, diagnosis, treatment, mitigation, or cure of COVID-19. “
Another illegal product allegedly offered by the company is chloroquine, marketed on the website as “Lariago-DS (chloroquine)”. The online pharmacy claims, “There are health professionals who use chloroquine (Lariago DS) along with zinc to fight COVID-19, the coronavirus.” And “The greatest benefit of chloroquine (Lariago DS) for the coronavirus is that it helps fight the intense fever. “
Although there are FDA-approved versions of chloroquine on the market in the US, there are no approved drug uses for the “Lariago-DS (Chloroquine)” offered by pharmacygeoff.md, according to the government.
“FDA-approved chloroquine is marked for the treatment of certain types of malaria and extraintestinal amebiasis and is only available by prescription,” the letter said. “In addition, chloroquine has not been approved by the FDA to prevent, diagnose, treat, mitigate, or cure COVID-19.”
Other products marketed by the Company as “Hivus-LR (lopinavir / ritonavir)”, “Lopimune (lopinavir / ritonavir)”, “Ribasure (ribavirin)” and “Dexona (dexamethasone)” also appear on the website under the heading “Coronavirus / COVID-19.”
In the “About Us” section of the website, Pharmacy Geoff describes itself as an online pharmacy that “has been in business for over four years and has over 10,000 customers worldwide, many of whom have been with us from day one”.
The company also states: “Pharmacy Geoff is subject to all regulations and laws of the Hong Kong Special Administrative Region. All products that are handled have been issued with the necessary import and export licenses issued by the Hong Kong Ministry of Health for each product individually. “
The FDA has given the company 48 hours of receiving the letter to contact the administration regarding specific steps their leadership plans to take to resolve the alleged violations.
If the matter is not handled appropriately, it can lead to legal action, including seizure and restraining order, according to the FDA.
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