WARNING LETTER
www.plakini-pharma.com
MARCS-CMS 705185 —
July 16, 2025
Product:
Drugs
Recipient:
www.plakini-pharma.com
Malaysia
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
FROM: The United States Food and Drug Administration
RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
DATE: July 16, 2025
WARNING LETTER
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.plakini-pharma.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)].
As discussed below, FDA has observed that www.plakini-pharma.com introduces into interstate commerce unapproved and misbranded opioids. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.
FDA has also observed that www.plakini-pharma.com introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co-use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co-used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines.
Finally, FDA has observed that www.plakini-pharma.com introduces into interstate commerce unapproved and misbranded Schedule II stimulants. Schedule II stimulants have an acknowledged high potential for abuse, and it is important to address the public health impact of their diversion and nonmedical use. Diversion is the primary source of prescription stimulants for nonmedical use, and nonmedical use is most frequent among young adults and college students. Polysubstance use is common among those who use prescription stimulants nonmedically, with individuals frequently co-using illicit drugs and/or prescription opioids. These concerns come against a backdrop of rising mortality from psychostimulant-involved overdoses, which involve illicit stimulants the vast majority of the time, but sometimes involve prescription stimulants. The easy availability of benzodiazepines and Schedule II stimulants via the Internet poses additional significant risks to U.S. consumers.
There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight.
Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.plakinipharma.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.
Unapproved New Drugs:
Certain products offered for sale by www.plakini-pharma.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. 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.
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. FDA-approved fentanyl is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. It is only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved fentanyl bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. This boxed warning addresses risks including addiction, abuse, misuse, lifethreatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when fentanyl is taken in conjunction with other central nervous system (CNS) depressants, including alcohol and benzodiazepines, use may result in coma or death.
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.
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.
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.
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.
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.
FDA-approved hydrocodone, tramadol, oxycodone, and brand names OXYCONTIN, PERCOCET, and DILAUDID, are each indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. They are only available pursuant to a prescription from a licensed practitioner.
Furthermore, FDA-approved hydrocodone, oxycodone, tramadol, OXYCONTIN, PERCOCET, and DILAUDID each bear a boxed warning, addressing risks including addiction, abuse, misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, and accidental exposure resulting in death. In addition, when hydrocodone, tramadol, oxycodone, OXYCONTIN, PERCOCET, or DILAUDID is taken in conjunction with other CNS depressants, including alcohol and benzodiazepines, use may result in coma or death.
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. FDA-approved benzodiazepine drug products are only available pursuant to a prescription from a licensed practitioner. Benzodiazepines also bear a boxed warning, addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
Two examples of unapproved Schedule II stimulants you offer for sale on www.plakini-pharma.com are:
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.
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.
ADDERALL and RITALIN are brand names for FDA-approved drugs indicated for the treatment of attention deficit hyperactivity disorders and narcolepsy. Using the brand name of the drug products ADDERALL and RITALIN indicates that these products are intended to treat attention deficit hyperactivity disorder and narcolepsy. FDAapproved ADDERALL and RITALIN are only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved ADDERALL and RITALIN each bear a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, ADDERALL and RITALIN can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including ADDERALL and RITALIN, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.
Misbranded Drugs:
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.
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)].
FDA is sending this warning letter to www.plakini-pharma.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address
this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.
If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.
Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
Sincerely,
/S/
Sangeeta Vaswani Chatterjee, Pharm.D.
Acting Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
07/29/2025
Regulated Product(s)
Drugs