# FDA WARNING_LETTER - American Pharmacy Group - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/american-pharmacy-group/40d3fa72-cd35-45a2-892a-1cf1c0f3d53a

> FDA WARNING_LETTER for American Pharmacy Group on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: American Pharmacy Group
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to American Pharmacy Group for offering unapproved new drugs and misbranded drugs for sale on multiple websites, including rxgreenovernight247.net and discreetdelivery.net. The products violate sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act.

Specifically, the websites sell hydrocodone and acetaminophen 10/500 mg, which is an unapproved new drug under section 201(p) and 505(a) of the FD&C Act. There are no FDA-approved applications for hydrocodone products containing 500 mg of acetaminophen, as the FDA requested manufacturers limit acetaminophen to 325 mg per tablet due to liver injury risks and withdrew approvals for higher strengths in 2014. Additionally, FDA-approved hydrocodone and acetaminophen products carry a boxed warning for serious risks like addiction, respiratory depression, and liver failure.

The product is also misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as it is a prescription drug requiring professional supervision. Its sale violates section 301(a) of the FD&C Act. The FDA expressed concern about the sale of hydrocodone products given the opioid abuse epidemic.

The FDA requires immediate cessation of marketing these violative drug products

## Related Officers

- [Office Director](https://www.globalkeysolutions.net/people/thomas-tj-christl/64bd97de-4180-46e9-a1a9-9b1230abaf24)

Company: https://www.globalkeysolutions.net/companies/american-pharmacy-group/908e9fda-4eeb-4591-935c-8afc7dc39d3c

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