# FDA WARNING_LETTER - rx2go.com - January 05, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/rx2gocom/76c4ce97-ed5d-47b5-b87c-aeaea7ea224d

> FDA WARNING_LETTER for rx2go.com on January 05, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: rx2go.com
- Inspection Date: 2021-01-05
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On January 28, 2021, the FDA issued a Warning Letter to www.rx2go.com following a January 5, 2021, review of their website. The FDA found that the website was offering unapproved and misbranded drug products for sale to U.S. consumers, including those claiming to mitigate, prevent, treat, diagnose, or cure COVID-19, lupus, rheumatoid arthritis, and malaria.

Specifically, the website offered "hydroxychloroquine sulfate (Generic Plaquenil)" and "Signaquine-200" manufactured by Signature. These products are considered unapproved new drugs under section 505(a) of the FD&C Act [21 U.S.C. § 355(a)] because no approved applications are in effect for them. The website misleadingly described these products as "FDA-approved," implying FDA approval for the specific versions sold, despite FDA-approved hydroxychloroquine being prescription-only and not approved for COVID-19.

Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] as they lack adequate directions for use by a layperson, being prescription drugs intended for conditions requiring professional supervision. The introduction of these products into interstate commerce violates sections 301(a

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/rx2gocom/292a401f-8b6b-4425-8fb8-6cdc9339affe

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