Category Archives: Regulators

FDA Issued Warning – Nobel Laboratories, LLC

October 21, 2010
2011-DAL-WL-001
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Fasprin Health, LLC / Nobel Laboratories, LLC
Attn: Edward J. Petrus, MD
President, Fasprin Health, LLC / Nobel Laboratories, LLC
3413 Spanish Oak Dr.
Austin, TX 78731

Dear Dr. Petrus:

This letter concerns “FASPRIN®” (Fasprin), which is marketed by your firm in quick dissolving tablet form as an over-the-counter (OTC) internal analgesic product. According to the package labeling, Fasprin is used for temporary relief of occasional headaches, minor aches and pains and for relief of fever (internal analgesic and antipyretic uses), as well as for various other uses. Fasprin’s package label identifies aspirin as the active ingredient and each tablet contains 81 mg of aspirin. Other labeling identifies glucosamine, zinc salt and magnesium salt as active ingredients for other drug uses, as described below.

The labeling for Fasprin contains statements that cause the product to be a drug, as defined by section 201 (g) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321 (g)).

The following are examples of intended drug uses described in the labeling for this product:

From the package label

• “Purpose[:] Pain Reliever/Fever Reducer”
• ”The Easy Way to Maintain Your Daily Aspirin Regimen” directly above a vignette of an EKG and a heart
• “Clinical Studies Indicate Low-Dose Aspirin Therapy Helps Reduce The Risk Of Heart Attack Or Stroke”
• “Daily Use Of Low-Dose Aspirin is Recommended By The American Heart Association”
• “Take FASPRIN For Emergency Treatment. At First Signs Of Heart Attack Or Stroke Call 911, Take Two FASPRIN ….”

Additional labeling claims from your websites,
(http://www.nobellabs.com/pages/fasprin.htmlhttp://www.fasprin.com and
http://www.fasprinhealth.com). and product brochure (available athttp://www.fasprin.com/)
• “ideal for: Daily low dosage aspirin therapy
Usage at the onset of symptoms of stroke …
Arthritis pain treatment.”
• “with regular use … reduces blood pressure and enhances blood flow in small vessels”
• “Additionally the FDA advises physicians to prescribe aspirin for patients with angina (chest pain), to reduce the risk of death in patients with a suspected acute heart attack, to prevent recurrent heart attacks, prevent stroke (blockage of blood flow to the brain), and treat transient ischemic attacks (mini-stroke)”
• “Every other day use of aspirin had a 44% reduction in the incidence of first myocardial infarction”
• After describing the process of a heart attack the website states “aspirin should be given within 1 hour of the start of heart attack symptoms.”
• “Fasprin also contains glucosamine to protect the lining of the mouth and GI tract; a zinc salt to promote healing of any ulcerationsplus to help prevent tinnitus associated with salicylates, and a magnesium salt to buffer the aspirin and decrease acid production in the stomach.”
• “Fasprin® incorporates glucosamine and a zinc salt to prevent any irritation.”
• “Figures show that long-term use of aspirin may double the chance of living a healthy life into your 90s!”
• “Low dose aspirin can reduce the risk [of Deep Vein Thrombosis] by 36 percent”
• “Did you know that the daily use of aspirin • Reduces the risk of stroke by 30% • Reduces the risk of Alzheimer’s disease by 50% • Reduces the risk of Parkinson’s disease by 45%”
• “Aspirin use is linked to lower rates of cancer”
• “Low dose aspirin reduces the risk of colon cancer by 50-60%”
• “Aspirin use treats and prevents periodontal disease”
• “Aspirin use reduced vision loss in elderly”
• “Aspirin prevents gall stone formation”
• “Aspirin may improve cognitive function in Alzheimer’s patients”

As labeled, Fasprin is a drug under section 201(g)(1)(B) of the Act (21 U.S.C. § 321 (g)(1)(B)), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man (e.g., cardiovascular-related diseases, arthritis, colon cancer, Alzheimer’s disease, Parkinson’s disease, gall stone formation, vision loss, periodontal disease, and longevity), and under section 201(g)(1)(C) of the Act (21 U.S.C. § 321 (g)(1)(C)), because it is intended to affect the structure or function of the body.

New Drug Violation

A. New indications for use, combination of active ingredients and dosage

Based on the combination of active ingredients and claims made for this product, Fasprin is a “new drug” within the meaning of section 201(p) of the Act (21 U.S.C. § 321(p)). Although the “Purpose” section of Fasprin’s Drug Facts panel states that Fasprin is intended as a “Pain Reliever/Fever Reducer,1Fasprin’s labeling claims demonstrate that one of its primary marketed intended uses is for cardiovascular-related diseases and events, including heart attacks, strokes and deep vein thrombosis. As described in 21 C.F.R. § 343.80, certain claims for the
treatment or prevention of cardiovascular- and cerebrovascular-related diseases are permissible only in professional labeling for aspirin. According to the labeling, Fasprin is also intended for arthritis pain treatment; reducing the risk of Alzheimer’s, Parkinson’s disease and colon cancer; treating and preventing periodontal disease, reducing vision loss; preventing gall stone formation; and increasing longevity. Fasprin’s uses for Alzheimer’s disease, Parkinson’s disease, colon cancer, periodontal disease, vision loss, gall stone formation, arthritis pain relief, and longevity are not covered by the tentative final monograph (TFM) for OTC internal analgesics (53 Fed. Reg. 46204, Nov. 16, 1988) or the final rule covering professional labeling for internal analgesics (63 Fed. Reg. 56802, Oct. 23, 1998). Moreover, we are not aware of evidence to show that Fasprin, as formulated and labeled, is generally recognized as safe and effective.

In addition, several of the above claims discuss Fasprin containing glucosamine, a zinc salt, and “a magnesium salt” intended for uses that represent and suggest they are active ingredients under 21 C.F.R. § 201.66(b)(2), based on the claims they are components intended to furnish pharmacological activity or other direct effect in the mitigation or treatment of disease or to affect the function of the body.2 The Internal Analgesics TFM did not include the combination of aspirin, glucosamine, zinc salt, and “a magnesium salt” as a combination of active ingredients, nor was this combination of ingredients evaluated as part of the Food and Drug Administration’s (FDA’s) OTC Drug Review for any of the internal analgesic/pain relief uses found in the labeling for Fasprin.

Also, the labeled directions for adult analgesic use of Fasprin specify a 81 mg daily dosage of “1 tablet daily” which falls within the range of the dosage listed in the professional labeling for aspirin for cardiovascular-related indications (see 21 C.F.R. § 343.80), but is well below the dosages for pain and fever relief that were’ considered in the Internal Analgesics TFM and OTC Drug Review. See 53 Fed. Reg. 46204 at 46257.

Therefore, based on the combination of active drug ingredients, dosage, and its labeled uses in mitigating, treating or preventing cardiovascular- and cerebrovascular-related diseases, Alzheimer’s disease, Parkinson’s disease, colon cancer, periodontal disease, vision loss, gall stone formation, arthritis pain relief, and longevity, as described above, Fasprin is a “new drug” within the meaning of section 201 (p) of the Act (21 U.S.C. § 321 (p)), as further described in 21 C.F.R. § 310.3(h), because it is not generally recognized as safe and effective for such labeled uses. Fasprin is not covered by FDA’s OTC Drug Review because no product formulated with this combination of active ingredients and dosage, and labeled for these intended uses has previously been commercially marketed on or before the inception of that review, and the Agency has never proposed that such a product be included in that Review. Thus, the current marketing of Fasprin violates section 505(a) of the Act (21 U.S.C. § 355(a)), because it is a “new drug” and it is not the subject of an approved new drug application.

B. New dosage form and method of administration

In addition, Fasprin for the uses described above is in a dosage form that is not generally recognized as safe and effective. According to its package labeling, Fasprin is a tablet that “Dissolves In Your Mouth Not In Your Stomach[,]” is ” • Fast Acting” and is ” • Quick Dissolv[ing].” According to its websites (http://www.nobellabs.com/pages/fasprin.html andhttp://www.fasprin.com), Fasprin “melts in the mouth after contact with saliva on the tongue and is absorbed by the lining of the mouth, avoiding first-pass metabolism” and “Get[s] into the blood stream faster,” such that, “[t]he protective action of aspirin is available within 5 minutes after absorption in the mouth.” Fasprin’s website “Q&A” goes on to explain “[s]ince Fasprin is absorbed by the lining of the mouth and carried with about 140 blood vessels, no tablet makes contact with the lining of the stomach to cause direct irritation.”

FDA is not aware of any evidence demonstrating that a fast acting quick dissolve internal analgesic tablet absorbed by the lining of the mouth was marketed at the inception of or considered under the OTC Drug Review. Because the dosage form is intended to avoid first-pass metabolism and be absorbed by the lining of the mouth unlike the dosage form covered by the Internal Analgesics TFM, without review of safety and efficacy data, the agency cannot conclude that such a dosage form is suitable for dosing conditions established under that TFM. A product that is initially marketed after the inception of the OTC Drug Review and that does not fully meet conditions established under the procedural regulation established in the OTC Drug Review is ineligible for the OTC Drug Review and requires an FDA-approved drug application before it can be legally marketed in the U.S. 21 C.F.R. §§ 330.1, and 330.10(b); 21 U.S.C. §§ 321(p) and 355(a).

As a result, Fasprin’s dosage form and method of administration are not generally recognized as safe and effective. 21 C.F.R. §§ 330.1, and 330.10(b). Therefore, Fasprin is a “new drug,” as defined in section 201(p) of the Act (21 U.S.C. § 321 (p)). See also 21 C.F.R. § 310.3(h)(5). The current marketing of Fasprin in the United States violates section 505(a) of the Act (21 U.S.C. § 355(a)), because it is a “new drug” and it is not the subject of an approved new drug application.

Misbranding Violations

Furthermore, Fasprin is misbranded under section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)) because it does not bear adequate directions for its intended cardiovascular and arthritis use. “Adequate directions for use” is defined in 21 C.F.R. § 201.5 as “directions under which the layman can use a drug safely and for the purposes for which it is intended.” Thus, if an indication requires the supervision of a practitioner licensed to prescribe drugs, adequate directions for use cannot be written for consumer directed OTC use. See U.S. v Articles of Drug, 625 F.2d 665, 672-673 (5th Cir. 1980). The directions are also inadequate under 21 C.F.R. §201.5 because the label does not include a “Uses” section as required by 21 C.F.R. § 201.66(c)(4) to identify the intended uses. In addition, Fasprin’s direction to take one 81 mg tablet daily is inadequate with respect to the aspirin doses considered under the OTC Drug Review for pain and fever relief and thus it is misbranded under 502(f)(1).

Fasprin is also misbranded under section 502(a) of the Act (21 U.S.C. § 352(a)) because the labeling of Fasprin as “The Easy Way to Maintain Your Daily Aspirin Regimen” is misleading when juxtaposed with the ten and three day limitations for pain and fever use, respectively, as set forth under the “Do Not Use” section and with the “take 1 to 4 tablets and repeat hourly, not to exceed 20 tablets during a 24 hour period” included on Fasprin’s website. The statements on the labeling send consumers a mixed message about the purpose of the product and the duration for which it can be safely used and as such the labeling is misleading. Additionally, because these labeled warnings are undermined by the inconsistent and incompatible language pertaining to the use as a daily regime with no time frame, Fasprin fails to bear adequate warnings against unsafe duration of administration and, therefore, is also misbranded under section 502(f)(2) of the Act (21 U.S.C. § 352(f)(2)).

Fasprin is also misbranded under 502(a) and 502(f)(2) because its immediate container, which is the blister card, does not contain the Reyes Syndrome warning as required for aspirin containing internal analgesic products under 21 C.F.R. § 201.314(h).

As previously discussed, Fasprin labeling claims that Fasprin contains glucosamine, a zinc salt, and “a magnesium salt” intended for uses that represent and suggest the ingredients are active ingredients under 21 C.F.R. § 201.66(b)(2). Accordingly, all three ingredients are required to be listed as active ingredients under 21 C.F.R. § 201.10 and 21 U.S.C. § 352(e)(1)(A)(ii). However, Fasprin’s label only lists glucosamine (Glucosamine Sulfate-K) and a zinc salt (Zinc Gluconate) as inactive ingredients and does not list any magnesium salt ingredient. As a result Fasprin is misbranded under 502(a) and 502(e)(1)(A)(ii).

Fasprin is further misbranded under section 502(e)(1)(A)(ii) of the Act (21 U.S.C. § 352(e)(1)(A)(ii)) because it fails to list and declare the quantity of all active ingredients. As previously discussed the glucosamine, zinc salt and “a magnesium salt” contained in Fasprin are active ingredients under 21 C.F.R. § 201.66(b)(2). Also, based on the labeled claims, “a magnesium salt” is present in the formulation, as noted above. However, there are no magnesium-containing ingredients listed on the package labeling. As neither glucosamine, zinc salt nor magnesium salt is listed as an active ingredient of Fasprin, the product is misbranded under section 502(e)(1)(A)(ii) of the Act.

In addition to the above violations, Fasprin is also misbranded under section 502(c) of the Act (21 U.S.C. § 352(c)), because the product is not labeled in accordance with the “Drug Facts” labeling requirements described in 21 C.F.R. § 201.66. For example, there is no “Uses” section under the “Drug Facts” as required by 21 C.F.R § 201.66(c)(4).

Finally, the introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301 (a) of the Act (21 U.S.C. § 331 (a)). Therefore, the marketing of Fasprin in the United States violates this provision of the Act.

The violations cited in this letter are not intended to be an all-inclusive list of deficiencies regarding your products, nor are the arguments raised here regarding them exhaustive. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the referenced violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Please send your reply to the Food and Drug Administration, Attention: Sherrie L. Krolczyk, Compliance Officer at the letterhead address. If you have questions regarding the content of this letter, please contact Sherrie L. Krolczyk at 214-253-5312.

Sincerely,

/S/

Reynaldo R. Rodriguez, Jr.
Dallas District Director
RRR/sik

———

1 Aspirin for use as a pain and fever reducing internal analgesic is addressed in the OTC Drug Review under the Tentative Final Monograph (TFM) issued on November 16, 1988 for OTC Internal Analgesics.

2 The specific glucosamine and zinc salt listed on Fasprin’s label are Glucosamine Sulfate-K and Zinc Gluconate, both of which are listed as inactive ingredients. While the labeling also discusses the use of a magnesium salt, there is no magnesium salt listed under either the active ingredient or inactive ingredient headers.

Stimul Media aka Rx Partners – stimul-cash.com

Buying Prescription Drugs Online Scam Alert 1
May Be Dangerous
Says Drug Enforcement Administration
DEA Logo - Buying Proscription Drugs
Click Here
National Association of Boards of Pharmacy (NABP)
Warning

“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.

Behind The Online Pharmacy

Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.

Buying Medication Online Can Be Safe


October 22, 2007
Stimul Media and Rx Partners relation
Filed under: reviews — Crevete @ 6:51 am
Today I signed up for two pharmacy affiliate programs: Rx Partners and Stimul Cash (former known as Stimul Media). As you know, signing up for these two is quite hard these days and you are required to have invitation code plus webmaster approval to start making money with them. Here is a conversation with the approval guy (Mark from Rx-Partners):

14:58:58 Me: Hello! I want to sign-up with stimul-media but the signup form does not appear. https://www.stimul-media.com/signup.html Please leave offline message if it’s the case.
11:32:00 stimul-media: please register here http://www2.stimul-cash.com/signup.html
13:18:31 Me: Hello! How can I sign-up on stimul-cash.com and give credit to a friend that reffered me? Is http://www2.stimul-cash.com/?partner=2331 going to work?
13:19:22 stimul-media: yes, it will work.
13:19:34 : ok, thanks
13:22:22 stimul-media: are you signing up in Rx-parterns as well?
13:22:38 Me: yes
13:22:51 Me: how did you know?
13:23:20 430886685: we run both programs
13:23:34 Me: I understand
13:23:42 430886685: can yo uplease tellme how exactly are you planning to advertisie our sites?
I will advertise on http://www.bubub.org/, search engine traffic.
13:25:15 430886685: I have apporved your account
13:25:23 Me: ok
13:25:31 Me: thank you
That’s a lot of money these dudes are making. Two of the top affiliate programs. Hope this shit will work for me. If you want to sign up with Rx Partners and need an invitation code please leave a comment, I will respond in less than an hour. Also if you need affiliate coaching don’t hesitate to

bother me.
Later!

Address lookup
canonical name http://www.stimul-cash.com
aliases
addresses 72.52.4.173
Domain Whois record

Queried whois.internic.net with “dom stimul-cash.com”…

Domain Name: WWW.STIMUL-CASH.COM
Registrar: REALTIME REGISTER BV
Whois Server: whois.yoursrs.com
Referral URL: http://www.realtimeregister.com
Name Server: NS0.STIMULCASH.COM
Name Server: NS1.STIMULCASH.COM
Status: clientTransferProhibited
Updated Date: 24-sep-2010
Creation Date: 16-mar-2007
Expiration Date: 16-mar-2013

>>> Last update of whois database: Wed, 13 Oct 2010 20:26:41 UTC <<<
Queried whois.yoursrs.com with “stimul-cash.com”…

Domain Name:stimul-cash.com
Name Server:ns1.stimulcash.com
Name Server:ns0.stimulcash.com

Created On:2010-08-13
Last Updated On:2010-09-24
Expiration Date:2013-03-16
Dealer:stimul
Registrant ID:stimul
Registrant Name:Vitaly Petrov
Registrant Organization:STIMUL-MEDIA.COM
Registrant Street1:Petrozavodskaya st, 16
Registrant Street2:
Registrant Street3:
Registrant City:Moscow
Registrant State/Province:
Registrant Postal Code:125414
Registrant Country:RU
Registrant Phone:+7.9160248086
Registrant Fax:
Registrant Email:vitalypetrov76@yahoo.com

Admin ID:stimul
Admin Name:Vitaly Petrov
Admin Organization:STIMUL-MEDIA.COM
Admin Street1:Petrozavodskaya st, 16
Admin Street2:
Admin Street3:
Admin City:Moscow
Admin State/Province:
Admin Postal Code:125414
Admin Country:RU
Admin Phone:+7.9160248086
Admin Fax:
Admin Email:vitalypetrov76@yahoo.com

Billing ID:stimul
Billing Name:Vitaly Petrov
Billing Organization:STIMUL-MEDIA.COM
Billing Street1:Petrozavodskaya st, 16
Billing Street2:
Billing Street3:
Billing City:Moscow
Billing State/Province:
Billing Postal Code:125414
Billing Country:RU
Billing Phone:+7.9160248086
Billing Fax:
Billing Email:vitalypetrov76@yahoo.com

Tech ID:stimul
Tech Name:Vitaly Petrov
Tech Organization:STIMUL-MEDIA.COM
Tech Street1:Petrozavodskaya st, 16
Tech Street2:
Tech Street3:
Tech City:Moscow
Tech State/Province:
Tech Postal Code:125414
Tech Country:RU
Tech Phone:+7.9160248086
Tech Fax:
Tech Email:vitalypetrov76@yahoo.com

Network Whois record
Queried whois.arin.net with “n 72.52.4.173″…

NetRange: 72.52.0.0 – 72.52.63.255
CIDR: 72.52.0.0/18
OriginAS:
NetName: PROLEXIC
NetHandle: NET-72-52-0-0-1
Parent: NET-72-0-0-0-0
NetType: Direct Allocation
NameServer: NS2.PROLEXIC.NET
NameServer: NS1.PROLEXIC.NET
Comment: http://www.prolexic.com / NOC hours are 24/7
RegDate: 2005-07-11
Updated: 2007-06-27
Ref: http://whois.arin.net/rest/net/NET-72-52-0-0-1

OrgName: Prolexic Technologies, Inc.
OrgId: PROLE
Address: 1930 Harrison Street
City: Hollywood
StateProv: FL
PostalCode: 33020
Country: US
RegDate: 2004-07-15
Updated: 2009-10-16
Ref: http://whois.arin.net/rest/org/PROLE

OrgTechHandle: HOSTM528-ARIN
OrgTechName: Hostmaster
OrgTechPhone: +1-866-800-0366
OrgTechEmail: hostmaster@prolexic.com
OrgTechRef: http://whois.arin.net/rest/poc/HOSTM528-ARIN

RTechHandle: HOSTM528-ARIN
RTechName: Hostmaster
RTechPhone: +1-866-800-0366
RTechEmail: hostmaster@prolexic.com
RTechRef: http://whois.arin.net/rest/poc/HOSTM528-ARIN
DNS records

name class type data time to live
stimul-cash.com IN MX
preference: 10
exchange: mail.stimul-cash.com
600s (00:10:00)
stimul-cash.com IN A 72.52.4.173 600s (00:10:00)
stimul-cash.com IN SOA
server: ns0.stimulcash.com
email: root.stimulcash.com
serial: 2010824934
refresh: 3600
retry: 900
expire: 604800
minimum ttl: 1200
600s (00:10:00)
stimul-cash.com IN NS ns0.stimulcash.com 600s (00:10:00)
stimul-cash.com IN NS ns1.stimulcash.com 600s (00:10:00)
173.4.52.72.in-addr.arpa IN PTR unknown.prolexic.com 86400s (1.00:00:00)
– end –
IP address: 72.52.4.173
Host name: stimul-cash.com
Alias:
stimul-cash.com
72.52.4.173 is from United States(US) in region North America

TraceRoute to 72.52.4.173 [stimul-cash.com]
Hop (ms) (ms) (ms) IP Address Host name
1 53 41 30 72.249.128.5 -
2 23 14 8 8.9.232.73 xe-5-3-0.edge3.dallas1.level3.net
3 Timed out 41 Timed out 66.192.240.94 dal2-pr1-ge-5-0-0-0.us.twtelecom.net
4 26 37 23 157.238.224.193 xe-0-4-0-1.r07.dllstx09.us.bb.gin.ntt.net
5 24 46 11 129.250.3.66 ae-6.r20.dllstx09.us.bb.gin.ntt.net
6 63 41 42 129.250.6.87 as-0.r21.miamfl02.us.bb.gin.ntt.net
7 48 47 41 209.200.132.34 blackhole.prolexic.com
8 51 69 80 157.238.179.6 ge-4-12.r02.miamfl02.us.ce.gin.ntt.net
9 51 44 55 209.200.132.34 blackhole.prolexic.com
10 69 80 58 72.52.4.173 unknown.prolexic.com
Trace complete

Retrieving DNS records for stimul-cash.com…
DNS servers
ns0.stimulcash.com
ns1.stimulcash.com
Query for DNS records for stimul-cash.com failed: Timed out
Whois query for stimul-cash.com…
Query error: Timed out
Network IP address lookup:

Whois query for 72.52.4.173…

Results returned from whois.arin.net:
#
# The following results may also be obtained via:
# http://whois.arin.net/rest/nets;q=72.52.4.173?showDetails=true&showARIN=false
#

NetRange: 72.52.0.0 – 72.52.63.255
CIDR: 72.52.0.0/18
OriginAS:
NetName: PROLEXIC
NetHandle: NET-72-52-0-0-1
Parent: NET-72-0-0-0-0
NetType: Direct Allocation
NameServer: NS2.PROLEXIC.NET
NameServer: NS1.PROLEXIC.NET
Comment: http://www.prolexic.com / NOC hours are 24/7
RegDate: 2005-07-11
Updated: 2007-06-27
Ref: http://whois.arin.net/rest/net/NET-72-52-0-0-1

OrgName: Prolexic Technologies, Inc.
OrgId: PROLE
Address: 1930 Harrison Street
City: Hollywood
StateProv: FL
PostalCode: 33020
Country: US
RegDate: 2004-07-15
Updated: 2009-10-16
Ref: http://whois.arin.net/rest/org/PROLE

OrgTechHandle: HOSTM528-ARIN
OrgTechName: Hostmaster
OrgTechPhone: +1-866-800-0366
OrgTechEmail: hostmaster@prolexic.com
OrgTechRef: http://whois.arin.net/rest/poc/HOSTM528-ARIN

RTechHandle: HOSTM528-ARIN
RTechName: Hostmaster
RTechPhone: +1-866-800-0366
RTechEmail: hostmaster@prolexic.com
RTechRef: http://whois.arin.net/rest/poc/HOSTM528-ARIN

#
# ARIN WHOIS data and services are subject to the Terms of Use
# available at: https://www.arin.net/whois_tou.html

FDA Warns of Bogus Pharmacy Site – Trustmeds.com

Buying Prescription Scam Alert 1Drugs Online May Be Dangerous Says Drug Enforcement Administration

DEA Logo - Buying Percription Drugs

National Association of Boards of Pharmacy (NABP)

Warning

“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.

Behind The Online Pharmacy

Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.

Buying Medication Online Can Be Safe

There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.


From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov      

 

Date: November 16, 2009
TO: Chris Walsh
c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903

TO: Chris Walsh
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009

Warning  Letter

The United States Food and Drug Administration (FDA) has reviewed your website at trustmeds.com and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Viagra (Brand),” and “Prozac (Generic).” We request that you immediately cease marketing violative products.
These products are drugs under section 201(g) of the 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. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unapproved New Drugs
Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.

Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, the “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant” dispensed through your website are “new drugs,” as defined by section 201(p) of the Act, 21 U.S.C. § 321(p).
Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant” without approved applications violates these provisions of the Act.
Misbranded Drugs
Your website offers numerous products, including but not limited to “Viagra (Brand)” and “Prozac (Generic)” for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301(a), 301(b), and 301(k) of such Act, 21 U.S.C. §§ 331(a), 331(b), and 331(k).
Further, your website offers products for sale and states that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a)of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act, 21 U.S.C. § 331(a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice. Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov or (301) 796-3110.
Sincerely,

/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research


Other Domains Associated With This Group

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  2. trusted-tabs.us
  3. terameds.org
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  15. preferredpharma.com
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  45. first-canadian-drugstore.com
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  60. medrugsleader.com
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  62. dprixe.com
  63. drugdeliverycenter.com
  64. pharmacy-usa.biz
  65. ukmed.biz
  66. duty-free-cigarettes.biz

FDA Warns of Bogus Pharmacy Sites

Buying Prescription Scam Alert 1Drugs Online May Be Dangerous Says Drug Enforcement Administration

DEA Logo - Buying Percription Drugs

National Association of Boards of Pharmacy (NABP)

Warning

“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.

Behind The Online Pharmacy

Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.

Buying Medication Online Can Be Safe

There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.


From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov

 

Date: November 16, 2009                                  

TO: Med Light LTD
37 Rectory Lane
PO Box 2063
Belize City, Belize

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903

TO: Med Light LTD

FROM: Food and Drug Administration Internet Pharmacy Task Force

RE: Internet Marketing of Unapproved and Misbranded Drugs

DATE: November 16, 2009

Warning Letter

The United States Food and Drug Administration (FDA) has reviewed your websites at

and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, “Acomplia (Brand),” “Acomplia (Generic),” “Rimonabant,” “Viagra (Brand),” “Cialis (Brand),” and “Prozac (Generic).” We request that you immediately cease marketing violative products.

These products are drugs under section 201 (g) of the 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. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:

Unapproved New Drugs

Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states.

Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective. Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, the “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant” dispensed through your websites are “new drugs,” as defined by section 201 (p) of the Act, 21 U.S.C. § 321(p).

Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant” without approved applications violates these provisions of the Act.

Misbranded Drugs

Your websites offer product for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner, including, but not limited to “Viagra (Brand),” “Cialis (Brand),” and “Prozac (Generic).” Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301(a), 301(b), and 301(k) of such Act, 21 U.S.C. §§ 331(a), 331(b), and 331(k).

Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.

The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act, 21 U.S.C. § 331(a).

This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov or (301) 796-3110.

Sincerely,

/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research

CC:
Chris Walsh c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.refill-rx-meds.com
http://www.brand-meds.com
http://www.rx-easy-pharmacy.com

Janis Larsen c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.buy-american-pharma.com
http://www.online-pharma-rx.com

Gordon Mcleod c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.first-american-pharmacy.com
http://www.secure-rx-refills.com

Katherine Wainscott c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.brand-pharma.com

PrivacyProtect.org
Domain Administrator
contact@privacyprotect.org
http://www.american-pharm.com
http://www.first-swiss-meds.com

Jacqueline Sockley c/o Dyndadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.rx-Iife.com

Domains by Proxy, Inc.
15111 N. Hayden Road
Ste 160 PMB 353
Scottsdale Arizona 85260
http://www.quickgeneric.com


Other Domains Associated With This Group

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  • rollinrollin.net
  • newhealthshop.net
  • generics-pharm.net
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  • duty-free-cigarettes.biz

 

FDA Warns of Bogus Pharmacy Sites

Buying Prescription Scam Alert 1
Drugs Online May Be Dangerous Says Drug Enforcement Administration


DEA Logo - Buying Percription Drugs

National Association of Boards of Pharmacy (NABP)

Warning

“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.

Behind The Online Pharmacy

Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.

Buying Medication Online Can Be Safe

There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.

 


From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov

Date: November 16, 2009

 

TO: New Horizons LTD                                                                        
Prol. Av. Independencia KM 20
Santo Domingo
Dominican Republic

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD.20903

TO: New Horizons LTD
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE:  Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009

Warning Letter

The United States Food and Drug Administration (FDA) has reviewed your websites at

and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Viagra (Brand),” “Cialis (Brand),” “Prozac (Generic),” and “Levitra (Brand).” We request that you immediately cease marketing violative products.

These products are drugs under section 201 (g) of the 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. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:

Unapproved New Drugs

Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated
sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.

Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts
among patients. Accordingly, the”Acomplia (Generic),·  Acomplia(Brand),· and “Rimonabant”
dispensed through your websites are “new drugs,” as defined by section 201(p) of the Act, 21 U.S.C. § 321(p).

Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Generic), “Acomplia (Brand),” and “Rimonabant” without approved applications violates these provisions of the Act.

Misbranded Drugs

Many of your websites sell products, including but not limited to “Viagra (Brand),” “Cialis (Brand)”, “Prozac (Generic),” and “Levitra (Brand)” without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301(a), 301 (b), and 301(k) of such Act, 21 U.S.C. §§ 331 (a), 331(b), and 331(k).

Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act.
Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.

The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301 (a) of the Act, 21 U.S.C. § 331 (a).

This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAlnternetPharmacyTaskForceCDER@ fda.hhs.govor (301) 796-3110.

Sincerely,

/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research

Cc:
Chris Walsh c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
top-drugstore. net

John Ruben c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
us-rx-meds.com

PrivacyProtect.org
Domain Admin
contact@privacyprotect.org
american-pharma.com
approved-swiss-pharm.com
approved-swiss-pharma.com
approved-swiss-pharmacy.com
first-swiss-dru gstore.com
first-swiss-pharm .com
first-swiss-pharmacy.com
mexican-pharma.com

Gordon Mcleod c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
central-rx-refill.com

Piter Krasnikov
745 Ushakova
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Russian Federation
midas ua@yahoo.com
cheapdrugsmd.com

Domains by Proxy, Inc., DomainsByProxy.com
15111 N. Hayden Rd., Ste 160, PMB 353
Scottsdale, Arizona 85260
PHARMACYTOUCH.COM@domainsbyproxy.com
pharmacytouch.com

WhoisGuard
8939 S. Sepulveda Blvd. #110 – 732
Westchester, CA 90045
lion-rx.com
mypillshop.com

 


 

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  86. farmaforum.biz
  87. pharmforum.biz

FDA Warning – 247meds. com

Buying Prescription Scam Alert 1Drugs Online May Be Dangerous Says Drug Enforcement Administration


DEA Logo - Buying Percription Drugs

National Association of Boards of Pharmacy (NABP)

Warning

“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.

Behind The Online Pharmacy

Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.

Buying Medication Online Can Be Safe

There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.


From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov

Date: November 16, 2009                                                          


TO: Ric Deleon
21 Villamor Street
Manila, Manila 2700
bastprices2000@yahoo.com
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903

TO: Ric Deleon
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009

WARNING LETTER

The United States Food and Drug Administration (FDA) has reviewed your websites at

and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,” “Herbal Ambien,” “Herbal Viagra,” “Viagra (Brand),” “Xanax (Brand),” and “Valium (Brand).” We request that you immediately cease marketing violative products.

These products are drugs under section 201 (g) of the 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. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:

Unapproved New Drugs

Your firm offers many unapproved new drugs including, but not limited to Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,· “Herbal Ambien,· and “Herbal Viagra.” FDA
is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.

Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts
among patients. Accordingly, the “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant,” dispensed through your websites are “new drugs,” as defined by section 201 (p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses.

You also offer “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” on your websites. Xanax, Ambien, and Viagra are approved drugs well-known for their intended use(s) to treat disease.
Therefore, including these drug names causes “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” to be subject to regulation as drugs under Section 201 (g) of the Act because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Moreover, these products are new drugs, as defined by section 201 (p) of the Act, 21 U.S.C. § 321 (p).

Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including but not limited to “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra,” without approved applications violates these provisions of the Act.

Misbranded Drugs

Your websites offer several products, including but not limited to “Viagra (Brand),” “Xanax (Brand),” and “Valium (Brand),” for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Some of the products available on your website are also controlled substances; the sale of these products is particularly concerning because of the potential for abuse and dependency. Therefore, the drugs are misbranded under section
503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301 (a), 301 (b), and 301 (k) of such Act, 21 U.S.C. §§ 331 (a), 331 (b), and 331 (k).

Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act.
Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.

In addition, you offer “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” for sale. These drugs are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs are false and misleading. The labeling are false and misleading because they erroneously suggest that the products contain Xanax, Ambien, and Viagra, which are the proprietary names for FDA-approved products containing the active pharmaceutical ingredients alprazolam,
zolpidem, and sildenafil citrate. Regardless of whether your products contain Xanax, Ambien, or Viagra, the products you are offering for sale are not manufactured by the sponsors of the approved applications for Xanax, Ambien, or Viagra, and it is false and misleading to suggest that
your products are manufactured by that sponsor.

The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301 (a) of the Act, 21 U.S.C. § 331 (a).

This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAlnternetPharmacyTaskForceCDER@fda.hhs.gov or (301) 796-3110.
Sincerely,

/S/

Deborah M. Autor, Esq.
Director
Office of Compliance


Address lookup

lookup failed 247meds. com
Could not find an IP address for this domain name.

Domain Whois record

Queried with “247meds. com”…

Query error: NoWhoisServerForDomain

Network Whois record

Don’t have an IP address for which to get a record

DNS records

DNS query for 247meds. com returned an error from the server: NameError

No records to display
– end –


IP address: 66.115.142.93
Host name: 247meds.com
Alias:
247meds.com
66.115.142.93 is from United States(US) in region North America

TraceRoute to 66.115.142.93 [247meds.com]
Hop (ms) (ms) (ms) IP Address Host name
1 30 61 57 72.249.128.5 -
2 52 35 11 8.9.232.73 xe-5-3-0.edge3.dallas1.level3.net
3 7 18 30 4.69.145.244 ae-93-90.ebr3.dallas1.level3.net
4 55 26 36 4.69.134.22 ae-7-7.ebr3.atlanta2.level3.net
5 32 31 26 4.69.148.254 ae-73-73.csw2.atlanta2.level3.net
6 33 28 28 4.69.150.68 ae-22-52.car2.atlanta1.level3.net
7 29 26 25 4.78.211.162 nationalnet.atlanta1.level3.net
8 30 35 44 66.115.128.114 gig2-10.tr1.atl4.national-net.com
9 62 57 42 66.115.142.93 pillcart.com
Trace complete

Retrieving DNS records for 247meds.com…
DNS servers
ns2.nationalnet.com
ns1.nationalnet.com

Answer records
247meds.com NS ns1.nationalnet.com 900s
247meds.com A 66.115.142.93 900s
247meds.com SOA
server: ns1.nationalnet.com
email: dnsadmin@nationalnet.com
serial: 2008042501
refresh: 28800
retry: 7200
expire: 604800
minimum ttl: 86400
900s
247meds.com NS ns2.nationalnet.com 900s

Authority records

Additional records
ns1.nationalnet.com A 216.201.81.254 900s
ns2.nationalnet.com A 216.201.87.28 900s

Whois query for 247meds.com
Results returned from whois.internic.net:

Domain Name: 247MEDS.COM
Registrar: GODADDY.COM, INC.
Whois Server: whois.godaddy.com
Referral URL: http://registrar.godaddy.com
Name Server: NS1.NATIONAL-NET.COM
Name Server: NS2.NATIONAL-NET.COM
Status: clientDeleteProhibited
Status: clientRenewProhibited
Status: clientTransferProhibited
Status: clientUpdateProhibited
Updated Date: 20-dec-2010
Creation Date: 11-mar-2003
Expiration Date: 11-mar-2012

Last update of whois database: Thu, 13 Jan 2011 11:43:14 UTC
Registrant:
Ric Deleon

Registered through: GoDaddy.com, Inc. (http://www.godaddy.com)
Domain Name: 247MEDS.COM

Domain servers in listed order:
NS1.NATIONAL-NET.COM
NS2.NATIONAL-NET.COM

For complete domain details go to:

http://who.godaddy.com/whoischeck.aspx?Domain=247MEDS.COM

Network IP address lookup:

Whois query for 66.115.142.93
Results returned from whois.arin.net:

The following results may also be obtained via:

http://whois.arin.net/rest/nets;q=66.115.142.93?showDetails=true&showARIN=false

NationalNet, Managed Services NATNET-MANAGED-VL255-BLK14 (NET-66-115-142-0-1) 66.115.142.0 – 66.115.142.255
NationalNet, Inc. NATIONALNET-1 (NET-66-115-128-0-1) 66.115.128.0 – 66.115.191.255

ARIN WHOIS data and services are subject to the Terms of Use
available at: https://www.arin.net/whois_tou.html

Results returned from whois.arin.net:

The following results may also be obtained via:

http://whois.arin.net/rest/nets;handle=NET-66-115-142-0-1?showDetails=true&showARIN=false

NetRange: 66.115.142.0 – 66.115.142.255
CIDR: 66.115.142.0/24
OriginAS: AS22384
NetName: NATNET-MANAGED-VL255-BLK14
NetHandle: NET-66-115-142-0-1
Parent: NET-66-115-128-0-1
NetType: Reassigned
RegDate: 2010-04-21
Updated: 2010-04-21
Ref: http://whois.arin.net/rest/net/NET-66-115-142-0-1

CustName: NationalNet, Managed Services
Address: 1130 Powers Ferry Place SE
City: Marietta
StateProv: GA
PostalCode: 30067
Country: US
RegDate: 2010-04-21
Updated: 2010-04-21
Ref: http://whois.arin.net/rest/customer/C02472880

OrgNOCHandle: NNO76-ARIN
OrgNOCName: NationalNet Network Operations
OrgNOCPhone: +1-678-247-7000
OrgNOCEmail: noc@nationalnet.com
OrgNOCRef: http://whois.arin.net/rest/poc/NNO76-ARIN

OrgTechHandle: IA88-ARIN
OrgTechName: IP Administrator
OrgTechPhone: +1-678-247-7000
OrgTechEmail: ipadmin@nationalnet.com
OrgTechRef: http://whois.arin.net/rest/poc/IA88-ARIN

OrgAbuseHandle: NAC69-ARIN
OrgAbuseName: NationalNet Abuse Contact
OrgAbusePhone: +1-678-247-7000
OrgAbuseEmail: abuse@nationalnet.com
OrgAbuseRef: http://whois.arin.net/rest/poc/NAC69-ARIN

RTechHandle: IA88-ARIN
RTechName: IP Administrator
RTechPhone: +1-678-247-7000
RTechEmail: ipadmin@nationalnet.com
RTechRef: http://whois.arin.net/rest/poc/IA88-ARIN

ARIN WHOIS data and services are subject to the Terms of Use
available at: https://www.arin.net/whois_tou.html


Other Known Domains Associated With This Group

  1. stimulhosting.com
  2. medpill.stimulhosting.com
  3. 247-meds.com
  4. relay.247-meds.com
  5. abouthealthy.com
  6. afmstore.com
  7. alfapills.com
  8. all-medication.com
  9. artelimbo.com
  10. best-pills-online.com
  11. bestpharmacyonline.net
  12. buy-pharmacy.info
  13. calidrugs.net
  14. ciais.net
  15. cvs-pharmacy.biz
  16. drug-store-online.net
  17. drugs24.net
  18. drugsline.net
  19. drugswebonline.com
  20. echeap-drugs.com
  21. extracheapdrugs.com
  22. firm-pharmacy.com
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  25. genericdrugsareus.com
  26. gldpharmacy.com
  27. govardwool.com
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  30. jofk.com
  31. love-pharmacy.org
  32. many-shop.com
  33. medications.stimulhosting.com
  34. medprivacy.net
  35. my-web-pills.com
  36. ns0.stimulhosting.com
  37. ns1.alfapills.com
  38. ns1.buy-pharmacy.info
  39. ns1.cvs-pharmacy.biz
  40. ns1.love-pharmacy.org
  41. ns1.medm.net
  42. ns1.pharmacyvia.net
  43. ns1.pittlearningsolutions.net
  44. ns1.stimulhosting.com
  45. ns1.worldsbestpharmacy.net
  46. ns2.alfapills.com
  47. ns2.buy-pharmacy.info
  48. ns2.cvs-pharmacy.biz
  49. ns2.love-pharmacy.org
  50. ns2.medm.net
  51. ns2.pharmacyvia.net
  52. ns2.pittlearningsolutions.net
  53. ns1.stimulhosting.com
  54. ns1.worldsbestpharmacy.net
  55. ns2.alfapills.com
  56. ns2.buy-pharmacy.info
  57. ns2.cvs-pharmacy.biz
  58. ns2.love-pharmacy.org
  59. ns2.medm.net
  60. ns2.pharmacyvia.net
  61. ns2.pittlearningsolutions.net
  62. ns2.worldsbestpharmacy.net
  63. onlinepharmacyfda.com
  64. order-cheap-meds.com
  65. orgasm-drugstore.com
  66. ovvl.com
  67. parcialis.com
  68. pharma37.com
  69. pharmacy-54.com
  70. pharmacytop.com
  71. pharmacyvia.net
  72. pharmamexpills.com
  73. pharmamexstore.com
  74. pharmamixx.com
  75. pharmocean.com
  76. pill-s.net
  77. pills-buy-now.com
  78. pillsmarket.net
  79. pillsstore.net
  80. relay.alfapills.com
  81. relay.buy-pharmacy.info
  82. relay.cvs-pharmacy.biz
  83. relay.love-pharmacy.org
  84. relay.medm.net
  85. relay.my-web-pills.com
  86. relay.nypdfoyle.com
  87. relay.pharmacyvia.net
  88. relay.pill-s.net
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  90. retreadthreads.com
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  92. rpvo.com
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  95. shinkatech.com
  96. sleline.com
  97. stimulhosting.com
  98. takeyourdrug.com
  99. thedrugmarket.com
  100. thepharmacy24.com
  101. top-medications.com
  102. ukusdrugs.com
  103. unkp.com
  104. usadrugsite.com
  105. viagr.net
  106. vkak.com
  107. wdxp.com
  108. wkum.com
  109. worldsbestpharmacy.net
  110. wvvd.com
  111. your-tablets.com

FDA Warns of andersenpharmacy.com & dukepharmacy.com

Buying Prescription Scam Alert 1Drugs Online May Be Dangerous Says Drug Enforcement Administration

DEA Logo - Buying Percription Drugs

National Association of Boards of Pharmacy (NABP)

Warning

“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.

Behind The Online Pharmacy

Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.

Buying Medication Online Can Be Safe

There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.

 


From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov

Date: November 16, 2009

 

TO: William Wynne
billandsveta@hotmail.com

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903

TO: William Wynne
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009

Warning Letter

The United States Food and Drug Administration (FDA) has reviewed your websites at andersenpharmacy.com and dukepharmacy.com and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to “Acomplia (Brand),” “Acomplia (Generic) “Rimonabant,” “Herbal Ambien,” “Herbal Xanax,” “Valium (Brand),” “Valium (Generic),” and “Prozac (Generic).” We request that you immediately cease marketing violative products.

These products are drugs under section 201 (g) of the 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. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:

Unapproved New Drugs

Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Brand),” “Acomplia (Generic),” “Rimonabant,” “Herbal Ambien,” and “Herbal Xanax.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients
altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.

Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, the “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant” dispensed through your websites are “new drugs,” as defined by section 201 (p) of the Act, 21 U.S.C. § 321 (p).

You also offer “Herbal Ambien,” and “Herbal Xanax,” on your websites. Ambien and Xanax are approved drugs well-known for their intended use(s) to treat disease. Therefore, including these drug names causes “Herbal Ambien” and “Herbal Xanax” to be subject to regulation as drugs under Section 201 (g) of the Act because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, these products are new drugs, as defined by section 201 (p) of the Act, 21 U.S.C. § 321 (p).

Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Brand),” “Acomplia (Generic),” “Rimonabant,” “Herbal Ambien,” and “Herbal Xanax” without approved applications violates these provisions of the Act.

Misbranded Drugs

Your websites offer numerous products, including but not limited to “Valium (Brand),” “Valium (Generic),” and “Prozac (Generic),” for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Some of the products available on your website are also controlled substances; the sale of these products is particularly concerning because of the potential for abuse and dependency. Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301 (a), 301 (b), and 301 (k) of such Act, 21 U.S.C. §§ 331 (a), 331 (b), and 331 (k).

Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.

In addition, you offer “Herbal Ambien” and “Herbal Xanax” for sale. These drugs are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is false and misleading. The labeling is false and misleading because it erroneously suggest that the products contain Ambien or Xanax, which are the proprietary names for FDA-approved products containing the active pharmaceutical ingredient zolpidem and alprazolam. Regardless of whether your products contain Ambien or Xanax, the products you are offering for sale are not manufactured by the sponsors of the approved applications for Ambien and Xanax, and it is false and misleading to suggest that your products are manufactured by those sponsors.

The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301 (a) of the Act, 21 U.S.C. § 331 (a).

This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDA lnternet Pharmacy  TaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at AlnternetPharmacyTaskForceCDER@fda.hhs.gov or (301) 796-3110.

Sincerely,

/S/

Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research

 


 

Address lookup

lookup failed andersenpharmacy.com
Could not find an IP address for this domain name.

Domain Whois record

Queried whois.internic.net with “dom andersenpharmacy.com”…

   Domain Name: ANDERSENPHARMACY.COM
   Registrar: WILD WEST DOMAINS, INC.
   Whois Server: whois.wildwestdomains.com
   Referral URL: http://www.wildwestdomains.com
   Name Server: NS1.SUSPENDED-FOR.SPAM-AND-ABUSE.COM
   Name Server: NS2.SUSPENDED-FOR.SPAM-AND-ABUSE.COM
   Status: clientDeleteProhibited
   Status: clientRenewProhibited
   Status: clientTransferProhibited
   Status: clientUpdateProhibited
   Updated Date: 17-nov-2009
   Creation Date: 29-oct-2005
   Expiration Date: 29-oct-2010

>>> Last update of whois database: Sun, 22 Nov 2009 08:53:01 UTC <<<

Queried whois.wildwestdomains.com with “andersenpharmacy.com”…

Registrant:
   OMR

   Registered through: JoJoDomains.com
   Domain Name: ANDERSENPHARMACY.COM

   Domain servers in listed order:
      NS1.SUSPENDED-FOR.SPAM-AND-ABUSE.COM
      NS2.SUSPENDED-FOR.SPAM-AND-ABUSE.COM

   For complete domain details go to:

Network Whois record

Don’t have an IP address for which to get a record

DNS records

DNS query for andersenpharmacy.com failed: WouldBlock

No records to display

– end –

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