Source: https://unapprovedpharmacy.com/category/fda-warning-regulators/
Timestamp: 2017-12-14 14:48:18
Document Index: 748239562

Matched Legal Cases: ['§ 355', '§ 503', '§503', '§ 352', '§ 353', '§ 352', '§ 331', '§ 503', '§ 503', '§ 355', '§ 352', '§ 331', '§ 503', '§503', '§ 355', '§ 352', '§ 331', '§ 355', '§ 355', '§ 352', '§ 331', '§ 355', '§ 503', '§ 503']

FDA Warning – scamFRAUDalert®Pharmacies Checker
FDA Warning Letter – Worldwide Drug Store
TO: Worldwide Drug Store
Another example of an unapproved new drug product offered on your websites is roxithromycin, which your websites claim “is used for treating several different infections, including some STDs, upper and lower respiratory tract infections and asthma, gum infections like gingivitis, and bacterial infections associated with stomach and intestinal ulcers.” There are currently no (and have never been) approved applications pursuant to section 505 of the FD&C Act
[21 U.S.C. § 355] in effect for roxithromycin in the U.S.
Your websites also offer prescription drugs for sale without a prescription. Prescription products, as defined in FD&C Act § 503(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. For example, both of the drugs identified above (chloramphenicol and roxithromycin) are prescription drugs as defined by FD&C Act §503(b)(1) offered for sale on your websites without a prescription. Chloramphenicol is associated with serious risks including, but not limited to, fatal aplastic anemia, and the approved labeling for this product, before it was withdrawn from sale, recommended extensive safety monitoring, including baseline blood studies followed by periodic blood studies approximately every 2 days.
A drug is also misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if it fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Because the aforementioned drugs are prescription drugs, intended for condition(s) 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(s). Consequently the labeling for these products fails to bear adequate directions for their intended use(s), causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115 from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, your websites are 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 taking this action against Worldwide Drug Store because of the inherent risk to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
buydrugsorderonline24.com
pharmacy-no-rx.com
cheapillsonline.com
buyzithromaxgeneric.net
buyzithromaxinusa.net
zithromaxonlinerxshop.net
buyciprofloxacinnorx.com
modernantibiotic.com
doxycyclinecheap.com
skypharmacy2016.com
canadianpharmaciesmailorder.net
onlinedrugstore24hour.com
silverpharmacy.com
antibioticseuromed.ru
antibioticsforsale.ru
antibioticsforsaleonline.ru
antibioticsonlineovernightdelivery.ru
antibioticsonlinepharmacy.ru
buyantibioticsonlineovernight.ru
buyantibioticswithoutprescriptionuk.ru
buyingantibioticsonline.ru
canadianonlinephamacyciproovernight.ru
flagyltablets.ru
mailorderantibiotics.ru
tetracyclineantibioticsforsale.ru
antibioticsforsaleonline.life
bestcanadiantabs.com
trusted-generic-pharmacy.com
spiritual-health.org
rxgolden.com
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی |English
FDA Warning Letter – Rx-Partners
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی
FDA Warning Letter – Pharmempire
TO: Pharmempire
Your websites also offer prescription drugs for sale without a prescription. Prescription products, as defined in the FD&C Act § 503(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. For example, both of the drugs identified above (chloramphenicol and roxithromycin) are prescription drugs under FD&C Act § 503(b)(1) and are offered on your websites without a prescription. Chloramphenicol is associated with serious risks including, but not limited to, fatal aplastic anemia. Additionally, the formerly FDA-approved chloramphenicol labeling recommended extensive safety monitoring, including baseline blood studies followed by periodic blood studies approximately every 2 days.
Another example of a misbranded drug offered on your websites is Keflex (cephalexin). Keflex is the brand name of a prescription drug approved by FDA to treat certain bacterial infections. The labeling for the FDA-approved product Keflex includes significant risks, including but not limited to, warnings concerning serious allergic reactions, severe watery or bloody diarrhea, anemia, and seizures.
FDA is taking this action against Pharmempire because of the inherent risk to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
amoxilamoxicillinfor-sale.com
amoxil-amoxicillin-order.com
buyonlinewithoutprescriptionvia.org
buyonlinewithoutprescriptionwqc.org
metronidazole-flagylantibiotic.net
amoxicillincaamoxil.org
buy-ciprofloxacinhcl500mg.com
online-usapharmacy.com
amoxiluk.org
amoxicillinonlineamoxil.org
amoxicillin-amoxil-without-prescription.net
amoxilnoprescription-amoxicillin.net
hyclate-100mg-doxycycline.net
amoxicillinamoxil-buy.net
no-prescription-amoxil-amoxicillin.com
amoxicillinamoxil-order.com
amoxilamoxicillin-for-sale.com
caamoxilamoxicillin.net
online500mg-cipro.net
500mgorder-flagyl.net
amoxilamoxicillinorder.com
ciprofloxacin-hcl-buy-500mg.org
metronidazole-flagyl-buy.net
cipro-withoutprescriptiononline.com
amoxiluk-amoxicillin.org
orderamoxicillinamoxil.org
ciprofloxacin500mgbuy.mobi
online-amoxicillinamoxil.net
amoxil-for-saleamoxicillin.net
amoxilno-prescriptionamoxicillin.net
online-buydoxycycline.org
flagyl-online-antibiotic.org
flagylantibiotic500mg.com
buy500mgciprofloxacinhcl.net
ciprofloxacin500mg-online.com
amoxilamoxicillin-forsale.org
flagyl-metronidazole-antibiotic.mobi
amoxilfor-saleamoxicillin.com
amoxicillinamoxil-withoutprescription.com
withoutprescription-amoxicillinamoxil.org
buy500mg-ciprofloxacin-hcl.net
buy500mg-cipro.com
amoxicillin-amoxilonline.net
online500mgciprofloxacin.net
amoxil-without-prescription-amoxicillin.com
flagylmetronidazoleantibiotic.org
amoxilamoxicillinca.net
flagylmetronidazoleantibiotic.com
buy-amoxilamoxicillin.net
buy-tabletscipro.net
antibiotichelp.com
ciprofloxacinhcl-buy500mg.com
amoxil-amoxicillin-generic.net
ciprofloxacinbuy-500mg.net
100mg-doxycyclinemono.net
amoxicillin-online-amoxil.com
100mgdoxycycline-hyclate.org
ciprofloxacinhcl500mgbuy.com
buyantibiotic-flagyl.net
without-prescriptionamoxil-amoxicillin.com
buy-500mg-ciprofloxacin-hcl.org
flagylbuying.com
withoutprescription-amoxicillin-amoxil.com
online-amoxicillin-amoxil.com
cipro500mg-buy.com
buyonlinewithoutprescriptionpiu.com
medicationsoverthecounter.com
pharmacyatwalmart.com
pharmexpress-rx.com
trustednorx.com
antibioticswithoutdoctorprescription.com
ciprofloxacin-hclbuy500mg.com
noprescriptionamoxilamoxicillin.net
amoxil-amoxicillinno-prescription.net
canadianpharmacy.tech
americanninedaylipost.com
genericviagraonlinenoscriptcheap.com
waytobehealthbluesea.com
sales-generic.com
amoxicillinamoxil-buy.com
pharmacyonline-noprescription.com
ciprofloxacin-hcl500mgtablets.com
buynoscriptwithoutpresctiptionotc.org
amoxicillinamoxilnoprescription.net
zithromax.me
goldentabs.com
4rx-pharmacy.org
canadian-pharmacy.website
canadianonlinepharmacy.website
planetmedpharmacy.com
tablrx.com
antibiotic-flagyl500mg.org
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی |
FDA Warning Letter – PharmCash
TO: PharmCash
An example of an unapproved new drug on your websites is oral chloramphenicol offered for sale under the brand name, Chloromycetin. Your websites claim “[Chloramphenicol] is used to treat serious infectious diseases such as meningitis, rickettsial disease, salmonellosis and anaerobic infections.” There are currently no approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for oral chloramphenicol. On September 21, 2016, it was announced in the Federal Register that FDA would not accept or approve abbreviated new drug applications (ANDAs) for chloramphenicol capsules, 50 mg, 100 mg, 250 mg, or chloramphenicol palmitate oral suspension, 150 mg/5 mL because FDA determined that previously approved versions of these chloramphenicol products were withdrawn from sale in the U.S. for reasons of safety or effectiveness. (81 FR 64914)
Because the aforementioned drugs are prescription products intended for condition(s) 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(s). Consequently, the labeling for these products fails to bear adequate directions for their intended use(s), causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because these drugs are not approved in the U.S., they are not exempt under 21 CFR 201.115 from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, your websites are 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)].
Your websites also offer prescription drugs for sale without a prescription. Prescription products, as defined in the FD&C Act § 503(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. For example, both chloramphenicol and Levaquin (levofloxacin) are prescription drugs as defined in the FD&C Act §503(b)(1) and are offered for sale on your websites without a prescription. Chloramphenicol is associated with serious risks including, but not limited to, fatal aplastic anemia and the approved labeling for this product, before it was withdrawn from sale, recommended extensive safety monitoring, including baseline blood studies followed by periodic blood studies approximately every 2 days.
Levaquin is the brand name of a prescription drug approved by FDA to treat certain bacterial infections. The labeling for the FDA-approved Levaquin product contains a boxed warning that addresses serious adverse reactions including tendinitis (tendon rupture or swelling of the tendon), peripheral neuropathy (changes in sensation and possible nerve damage), central nervous system effects (e.g., convulsions, dizziness, lightheadedness, increased intracranial pressure), and exacerbation of myasthenia gravis (a chronic disease that causes muscle weakness).
FDA is taking this action against PharmCash because of the inherent risk to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
buyacyclovirzovirax.net
buyflagylmetronidazole.net
buyingantibioticsonline.net
nextdaydeliverys.com
doxycycline-pro.com
med-store.net
yourtrustprescriptionsupplier.net
buy-antibiotics.org
pillsfromcanada.com
myantibiotics.org
overnightsdeliverys.com
goldmeds.net
fda-approved-rx.biz
internetpharmacydir.com
antimicrobialmed.com
amoxil-amoxicillin-pro.com
no-rxdrugs.com
rxmedsdoctor.net
without-prescription.com
asiapharm.net
commonrx.com
drugs-rx-pharmacy.com
greatpillonline.com
FDA Warning Letter – MyRXCash
TO: MyRXCash
For example, your websites offer tramadol, marketed as “tramadol 50 mg/ml,” described as an “immediate-release oral formulation” that is “used to treat pain and discomfort ranging from mild to severe cases….” While there are FDA-approved versions of tramadol in tablet and capsule form on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for the “tramadol 50 mg/ml” oral solution product marketed on your websites. FDA-approved tramadol 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. The boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when taken in conjunction with other central nervous system depressants, including alcohol, use may result in coma or death.
Because the aforementioned drug is a prescription product intended for condition(s) that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use this product safely for its intended use(s). Consequently, the labeling for this product fails to bear adequate directions for its intended use(s), causing it to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because “tramadol 50 mg/ml” is not approved in the U.S., it is also not exempt under 21 CFR 201.115 from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to U.S. consumers, your websites are 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)].
Offering tramadol for sale on your websites is particularly concerning given its potential for abuse and dependency, especially amid the growing epidemic of opioid abuse in the U.S. The Centers for Disease Control and Prevention found that opioid overdose deaths involving prescription opioids have quadrupled since 1999, and in 2015, opioids were involved in the deaths of 33,091 people in the U.S.[1] In addition, deaths by drug overdose, including overdose from prescription opioids, are now the leading cause of injury death in the U.S.\
FDA is taking this action against MyRXCash because of the inherent risk to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
directpharmas.net
buypropeciashop.net
rx-checkout.net
buyimovane.com
buysonataonline.com
buyzaleplononline.com
buyzopicloneonline.com
canadapillstore.com
canadatabs.com
drugs-medstore.com
drugs-ship.com
rx-rev.com
trusts-rx.com
24×7-pillstore.net
buylunestaonline.net
cadrugstore.net
canadatabs.net
canadianmedstore.net
canadianpillstore.net
directspharma.com
[1] Drug Overdose Death Data, Centers for Disease Control and Prevention, athttps://www.cdc.gov/drugoverdose/data/statedeaths.html [Accessed August 28, 2017].
FDA Warning Letter – MediPK
TO: MediPK
For example, your websites offer unapproved new drugs such as tramadol, marketed as “Tonoflex SR” and described as “a medication used to treat pain that is moderate to severe.” 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 [21 U.S.C. § 355] in effect for the “Tonoflex SR” product marketed on your websites. FDA-approved tramadol 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. The boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when taken in conjunction with other central nervous system depressants, including alcohol, use may result in coma or death.
Your websites also offer for sale unapproved codeine products such as “Brufen Plus+” which is described on the image of the label on your websites as containing codeine and ibuprofen and “Powerful Double Action for Pain Relief.” While there are FDA-approved codeine products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for the “Brufen Plus+” product marketed on your websites. There are also no approved drug applications in the U.S. for products that contain the combination of codeine and ibuprofen. FDA-approved codeine bears a boxed warning that addresses risks including addiction, abuse, misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome. In addition, when taken in conjunction with other central nervous system depressants, including alcohol, use may result in coma or death.
Because the aforementioned drugs are prescription products intended for condition(s) that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use these products safely for their intended use(s). Consequently, the labeling for these products fails to bear adequate directions for their intended use(s), causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115 from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, your websites are 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)].
Offering these drugs for sale on your websites is particularly concerning given their potential for abuse and dependency, especially amid the the growing epidemic of opioid abuse in the U.S. The Centers for Disease Control and Prevention found that opioid overdose deaths involving prescription opioids have quadrupled since 1999, and in 2015, opioids were involved in the deaths of 33,091 people in the U.S.[1] In addition, deaths by drug overdose, including overdose from prescription opioids, are now the leading cause of injury death in the U.S.
FDA is taking this action against MediPK because of the inherent risk to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
clinixplus.com
ourezee.com
chemicalsupplyltd.net
clinixplus.net
ahpharmacy.com
clinixmass.com
healthdrugsforu.com
jaishaenterprises.com
lookandtook.com
mallofmedicine.com
medicomedicine.com
anabolicneeds.net
clinixmass.net
mallofmedicine.net
medicomedicine.net
hexameds.com
steroidxone.com
medi-pk.com
pakonlinepharmacy.com
thepharmacyplus.com
zafaxpharma.com
[1] Drug Overdose Death Data, Centers for Disease Control and Prevention, at https://www.cdc.gov/drugoverdose/data/statedeaths.html [Accessed August 28, 2017].
FDA Warning Letter – Medicina Mexico
TO: Medicina Mexico
An example of an unapproved new drug on your websites is chloranfenicol (also known as chloramphenicol) offered for sale under the brand name, Lebrocetin. Your websites claim that chloranfenicol is an “antibiotic indicated for typhoid, paratyphoid, rickettsial, brucellosis, meningitis, endocarditis, osteomyelitis, bacteremia and infections caused by anaerobic bacteria.” There are currently no approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for oral chloramphenicol. On September 21, 2016, it was announced in the Federal Register that FDA would not accept or approve abbreviated new drug applications (ANDAs) for chloramphenicol capsules, 50 mg, 100 mg, 250 mg, or chloramphenicol palmitate oral suspension, 150 mg/5 mL because previously approved versions of these chloramphenicol products were determined to have been withdrawn from sale in the U.S. for reasons of safety or effectiveness. (81 FR 64914)
Prior to being removed from the market, the approved labeling for these products contained a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating the drug carries a significant risk of serious or life-threatening adverse effects. The boxed warning for chloramphenicol indicated that serious and sometimes fatal blood disorders [e.g., hypoplastic or aplastic anemia (very few or no blood cells in bone marrow), thrombocytopenia (low blood platelet counts), and granulocytopenia (low white blood cell counts)] are known to occur after administration of chloramphenicol. The boxed warning further described aplastic anemia attributed to chloramphenicol that later resulted in leukemia. In determining that these products had been withdrawn for reasons of safety and effectiveness, FDA relied on the fact that additional therapies with less severe adverse drug effects have been approved, and that, therefore, the risks associated with these chloramphenicol products as labeled outweighed the benefits.
Your websites also offer prescription drugs for sale without a prescription. Prescription products, as defined in the FD&C Act § 503(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. For example, both chloramphenicol and Levaquin (levofloxacin) are prescription drug products as defined in the FD&C Act § 503(b)(1) that are offered for sale on your websites without a prescription. Chloramphenicol is associated with serious risks including, but not limited to, fatal aplastic anemia and the approved labeling for this product, before it was withdrawn from sale, recommended extensive safety monitoring, including baseline blood studies followed by periodic blood studies approximately every 2 days.
FDA is taking this action against Medicina Mexico because of the inherent risk to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
americanonlinepharmacy.com
buymeds4less.com
buymedsonlinenow.net
buyrxmedsnow.com
orderyourmedsonline.com
rxonline.com.mx