www.bigpharmausa.com

Selected passages from the FDA letter

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

Passage 1

No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.

Passage 2

Your description of tramadol marketed as “Generic Tramadol 200 mg,” “Tramadol 200 mg Tabletas,” and “Tramadol 200 mg drug (L011 Pill)” includes: “This medication is approved by the Food and Drug Administration (FDA) for managing moderate to severe pain mainly in adults.”

Passage 3

Your description of oxycodone marketed as “Generic Oxycodone 20 mg” and “Oxycodone 20 mg (M 20 Pill)” includes: “Oxycodone 20 mg (M 20 Pill) is a strong opioid medication that can be used for treating mild to severe pain.”

Passage 4

Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the product safely for the intended use. Consequently, the labeling for these drugs fail to bear adequate directions for use, 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, www.bigpharmausa.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act.