www.plakini-pharma.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

One example of an unapproved opioid you offer for sale on www.plakini-pharma.com is fentanyl, marketed as “Buy fentanyl patches 75mcg Online” and pictured as “fentanyl transdermal system.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Buy fentanyl patches 75mcg Online Fentanyl [sic] used for Fentanyl patches are used for long lasting pain relief for constant, around the clock cancer pain.” While there are FDA-approved versions of fentanyl on the market in the U.S., including for the transdermal route of administration, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy fentanyl patches 75mcg Online” offered by www.plakini-pharma.com.

Passage 3

Additional examples of unapproved opioids you offer for sale on www.plakini-pharma.com are: Hydrocodone marketed as “Buy Hydrocodone Online,” “Buy Hydrocodone Watson Online,” and “Hydrocodone Watson Online 853 espanol.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Buy Hydrocodone Online , [sic] Hydrocodone is an opioid used to treat pain and as a cough suppressant” and “Purchase Hydrocodone 853 español is a remedy pain relieving used to get moderate reasonably extreme agony [sic], and it’s regularly given in mix with acetaminophen.” While there are FDA-approved versions of hydrocodone 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 “Buy Hydrocodone Online,” “Buy Hydrocodone Watson Online,” and “Hydrocodone Watson Online 853 espanol” offered by www.plakini-pharma.com.

Passage 4

Tramadol marketed as “Buy original Tramadol 250mg,” “tramadol 50 mg,” and “TRAMADOL-X225.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Buy original Tramadol 250mg Tramadol, sold under the brand name Ultram among others, s [sic] an opioid pain medication used to treat moderate to moderately severe pain.” 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 “Buy original Tramadol 250mg,” “tramadol 50 mg,” and “TRAMADOL-X225” offered by www.plakini-pharma.com.

Passage 5

Oxycodone marketed as “Buy Oxycodone 10mg Online,” “Buy Oxycodone 30mg (A215) Online,” “Buy Oxycodone 80mg Online,” and “OxyContin 80 mg.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “Buy Oxycodone 10mg Online Oxycodone… is an opioid medication used for treatment of moderate to severe pain,” “This help [sic] to keep you relief and is the world best pain medication Buy Oxycodone 30mg (A215) Online [sic],” “Onset of pain relief typically begins within fifteen minutes and lasts for up to six hours with the immediate-release formulation,” and “Buy Oxycodone 80mg Online Oxycodone... is an opioid medication used for treatment of moderate to severe pain.” While there are FDA-approved versions of oxycodone 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 “Buy Oxycodone 10mg Online,” “Buy Oxycodone 30mg (A215) Online,” “Buy Oxycodone 80mg Online,” and “OxyContin 80 mg” offered by www.plakini-pharma.com.

Passage 6

Oxycodone and acetaminophen marketed as “Buy Percocet 10mg online.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes its categorization under “RX Drugs.” While there are FDA-approved versions of oxycodone and acetaminophen 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 “Buy Percocet 10mg online” offered by www.plakini-pharma.com.

Passage 7

Hydromorphone marketed as “Buy high quality Dilaudid 8mg.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Buy high quality Dilaudid 8mg, Dilaudid is a potent opioid analgesic used to treat moderate and severe pain. The drug influences the human brain, blocking its response to pain.” While there are FDA-approved versions of hydromorphone 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 “Buy high quality Dilaudid 8mg” offered by www.plakini-pharma.com.

Passage 8

An example of an unapproved benzodiazepine you offer for sale on www.plakini-pharma.com is flunitrazepam marketed as “Buy Rohypnol Online” and “Rohypnol Flunitrazepam 1 mg 30 Filmtabletten.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Buy Rohypnol Online Rohypnol, also known as flunitrazepam among other names [sic] benzodiazepine used to treat severe insomnia and assist with anesthesia.” While there are FDA-approved benzodiazepine drug products 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 flunitrazepam.

Passage 9

Amphetamine marketed as “Buy Adderall 20mg (XR),” “Buy Adderall 20mg IR online,” “Buy Adderall 25mg XR online,” and “Buy Adderall 30mg IR online.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “Adderall is generally well tolerated and effective in treating the symptoms of ADHD and narcolepsy. At therapeutic doses, Adderall causes emotional and cognitive effects such as euphoria, change in sex drive, increased wakefulness, and improved cognitive control,” “Buy Adderall 20mg IR online of one of the best retailers online at the best price. [sic] is also known as amphetamine and dextroamphetamine used for the treatment of ADHD,” and “It is also used as an athletic performance enhancer and cognitive enhancer, and recreationally as an aphrodisiac and euphoriant.” While there are FDA-approved versions of amphetamine 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 “Buy Adderall 20mg (XR),” “Buy Adderall 20mg IR online,” “Buy Adderall 25mg XR online,” and “Buy Adderall 30mg IR online” offered by www.plakini-pharma.com.

Passage 10

Methylphenidate marketed as “Buy Ritalin 10mg online,” “Ritalin 10 30 Tablette,” and “Ritalin tablet 10 mg 3x10s.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Buy Ritalin 10mg online Methylphenidate, sold under the brand names Ritalin and Concerta among others, is a central nervous system (CNS) stimulant medication used to treat attention deficit hyperactivity disorder (ADHD) and, to a lesser extent, Ritalin methylphenidate 10mg online narcolepsy [sic].” While there are FDA-approved versions of methylphenidate 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 “Buy Ritalin 10mg online,” “Ritalin 10 30 Tablette,” and “Ritalin tablet 10 mg 3x10s” offered by www.plakini-pharma.com.

Passage 11

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 products safely for their 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. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.plakini-pharma.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].