# FDA WARNING_LETTER - Ivermectin24h.com - March 15, 2022

Source: https://www.keypedia.com/records/warning_letter/ivermectin24hcom/2126b9a5-4cab-4e21-8001-c96f02525eec

> FDA WARNING_LETTER for Ivermectin24h.com on March 15, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Ivermectin24h.com
- Inspection Date: 2022-03-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On February 25, 2022, the FDA issued a Warning Letter to www.ivermectin24h.com following a website review on December 13, 2021. The FDA observed the website offering drug products, including "Hydroxychloroquine," for sale in the U.S., claiming to mitigate, prevent, treat, diagnose, or cure COVID-19 and other diseases like malaria, lupus erythematosus, and rheumatoid arthritis.

The FDA determined these products are misbranded drugs under section 503(b) of the FD&C Act [21 U.S.C. § 353(b)]. Specifically, hydroxychloroquine is a prescription drug under section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)] due to its toxicity and potential for harmful effects, requiring supervision by a licensed practitioner. The website offers this drug without requiring a prescription, violating section 503(b)(1) and section 301(k) of the FD&C Act [21 U.S.C. § 331(k)]. Furthermore, offering these drugs for sale to U.S. consumers causes the introduction of misbranded drugs into interstate commerce, violating section 301(a) of the FD&C Act [21

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- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)

Company: https://www.keypedia.com/companies/ivermectin24hcom/24b56d1c-ce06-4249-961d-762dd35b144d

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c