Import Alert 66-46
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 66-46
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Rodaquin"
Reason for Alert:
Rodaquin, alleged to be a mixture of oxidation reduction compounds (i.e, tetrahydroxyuquinone, rhodizonic acid, triquinoyl, polycarbon suboxide, and two "polymers") in a liquid vehicle, has been in circulation as a "drug" for at least 25 years. It has been promoted as a cancer treatment and more recently as an effective treatment for a wide variety of serious diseases and medical disorders such as stroke, paralysis, Parkinson's Disease, cardiovascular conditions, neurofibromatosis, and keloids.
Rodaquin is often accompanied by literature, promoting its alleged benefits, which is mailed by the referenced importer who is also believed to be the owner and operator of the manufacturing firm in Mexico. The literature consists largely of testimonials for cures of conditions for which Rodaquin has not been proven to be safe or effective. The drug is also promoted by several "Friends of Rodaquin" groups, both in the U.S. and Mexico, which are listed in the literature supplied to consumers.
The product apparently is brought into the U.S. from 4(b) , which operates also as a clinic, by patients visiting the clinic or is smuggled across the border and shipped within the U.S.
In addition to the investigations that LOS DO has conducted to establish the involvement of the named importer, LOS DO has also received through DET DO, a packet of information,including a different set of letters and testimonials, received from a consumer.
Rodaquin is often accompanied by literature, promoting its alleged benefits, which is mailed by the referenced importer who is also believed to be the owner and operator of the manufacturing firm in Mexico. The literature consists largely of testimonials for cures of conditions for which Rodaquin has not been proven to be safe or effective. The drug is also promoted by several "Friends of Rodaquin" groups, both in the U.S. and Mexico, which are listed in the literature supplied to consumers.
The product apparently is brought into the U.S. from 4(b) , which operates also as a clinic, by patients visiting the clinic or is smuggled across the border and shipped within the U.S.
In addition to the investigations that LOS DO has conducted to establish the involvement of the named importer, LOS DO has also received through DET DO, a packet of information,including a different set of letters and testimonials, received from a consumer.
Guidance:
Districts may detain detain all shipments of Rodaquin from Mexico.
The applicable charge will be made based on whether or not the shipment is accompanied by the literature.
Alert your local Customs office and Postal Service of our interest in this product and that it may be entered as formal and informal entries by personal shipments or by mail.
>>4(b)>IMPORTER:
Steven R. Winslow,P.O. Box 1985,Chula Vista, CA<<
The applicable charge will be made based on whether or not the shipment is accompanied by the literature.
Alert your local Customs office and Postal Service of our interest in this product and that it may be entered as formal and informal entries by personal shipments or by mail.
>>4(b)>IMPORTER:
Steven R. Winslow,P.O. Box 1985,Chula Vista, CA<<
Product Description:
Rodaquin, oral solution in 10 ml ampules
Charge:
When accompanied by drug claims, charge:
"The article is subject to refusal of admisssion pursuant to 801(a)(3) in that it appears the labeling fails to bear adequate directions for use for its intended purposes [misbranded; 502(f)(1)] and it appears to be a new drug without an effective new drug application [Unapproved new drug; 505(a)]".
OASIS Charge Code - UNAPPROVED
When unaccompanied by drug claims, charge:
"The article is subject to refusal of admission pursuant to 801(a)(3) in that it appears the labeling fails to bear adequate directions for use for its intended purposes [Misbranded; 502(f)(1)]".
OASIS Charge Code - DIRECTIONS
"The article is subject to refusal of admisssion pursuant to 801(a)(3) in that it appears the labeling fails to bear adequate directions for use for its intended purposes [misbranded; 502(f)(1)] and it appears to be a new drug without an effective new drug application [Unapproved new drug; 505(a)]".
OASIS Charge Code - UNAPPROVED
When unaccompanied by drug claims, charge:
"The article is subject to refusal of admission pursuant to 801(a)(3) in that it appears the labeling fails to bear adequate directions for use for its intended purposes [Misbranded; 502(f)(1)]".
OASIS Charge Code - DIRECTIONS
Countries
MEXICO
(66 ! - ! --)
MEXICO
Laboratorios Rodaquina S.A.
Date Published : 09/10/2009
Unknown Street , Ensenada, Baja California MEXICO
66 - - - -- Human and Animal Drugs
Date Published: 09/10/2009
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