IA #66-46 - 6/6/89, "Unapproved Version of Rodaquin"
TYPE OF ALERT: Automatic detention
PRODUCT : Rodaquin, oral solution in 10 ml ampules
PRODUCT CODE : 66 ()()()()()
PROBLEM : New drug without an approved new drug application
(DRND and labeling lacks adequate directions for
intended use (DRDW)
PAC : 56008H
COUNTRY : Mexico (595)
MANUFACTURER/
SHIPPER : Laboratorios Rodaquina S. A.
Ensenada, Baja California, Mexico
IMPORTER : ^ ^
^ ^
^ ^
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)]".
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)]".
RECOMMENDING
OFFICE : LOS-DO
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 Laboratorios Rodaquin, 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.
INSTRUCTIONS : Automatically 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.
FOI : Information between ^ ^ requires purging.
KEYWORDS : Rodaquin, Mexico, drug, fraud
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