PowerAll Pharma

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

While there are FDA‐approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Tramadol LP Zentiva 50 mg” and “Tramadol Arrow LP 100 mg” offered by PowerAll Pharma.

Passage 2

There are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Opana ER (Oxymorphone)” offered by PowerAll Pharma.

Passage 3

there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Valium Pills (Diazepam)” offered by PowerAll Pharma.

Passage 4

Consequently, the labeling for these drugs fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FD&C Act.

Passage 5

By offering the aforementioned drugs without requiring a prescription, PowerAll Pharma jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act.