IA#66-20, 9/22/92 REVISED
TYPE OF ALERT: Automatic Detention
PRODUCT : Mexican Folk remedies such as Azoque, Greta,
Azarcon, and other similar products
PRODUCT CODE : 66V--99
HARMONIZED
CODE : N/A
PROBLEM : New Drug without an approved New Drug Application
(NDA) (DNRD) and labeling lacks adequate
directions for intended use (DVDW)
PAC FOR
COLLECTION : 56008H
COUNTRY : Mexico, (MX,595), and others from which similar
products are shipped.
MANUFACTURER/
SHIPPER : All
MANUFACTURER/
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. # : N/A
CHARGE : "The article is subject to refusal of admission
within the meaning of Section 801(a)(3) in that
it appears to be a new drug without an approved
New Drug Application (NDA) [Unapproved New Drug,
505(a)]; and the labeling fails to bear adequate
directions for use for its intended purpose
[Misbranded, Section 502(f)(1)]."
RECOMMENDING
OFFICE : CDER/Office of Compliance, Health Fraud Staff,
(HFD-304)
REASON FOR
ALERT : The Food and Drug Administration received
information from the California State Health
Department that they had seized containers of a
Mexican folk remedy called "Azoque" being offered
for sale at a San Jose store specializing in
Latin American Imports. Other similar Mexican
folk remedies called "Greta", "Azarcon", "Rueda",
"Coral", "Alarcon", "Liga", and "Maria Luisa"
were previously known to be offered for sale in
the Hispanic communities throughout the U.S.,
predominantly among migrant workers in south
Texas, California, and Florida.
These products reportedly are recommended for the
treatment of empacho (a general Spanish term for
indigestion, diarrhea, and other stomach and
intestinal illnesses) and are primarily given to
infants and children. There is some adult use.
Azoque, is the Spanish term for mercury which is
poisonous.
Mercury and its salts are absorbed through the
mucous membranes and are toxic, especially to
persons exposed to them for extended periods of
time. Azarcon and Greta are orange and yellow
powders containing lead which pose significant
hazards especially to children. Greta, for
example, is approximately 99 percent lead oxide.
"Rueda", "Coral", "Alarcon", "Liga", and "Maria
Luisa" are also believed to be lead containing
compounds. Use of these products may result in
neurological disturbances including seizures,
coma, and death.
INSTRUCTIONS : Detain, without analysis, shipments of "Azarcon",
"Rueda", "Coral", "Alarcon", "Liga", and "Maria
Luisa" or any other products that the district
determines to be similar either from Mexico or
other countries when presented for entry.
PRIORITIZATION
GUIDANCE : N/A
FOI : No purging required
KEYWORDS : Folk remedy, Azoque, Greta, Azarcon, Alarcon,
Rueda, Coral
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.
|