Import Alert 66-20
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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 # 66-20
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Azoque - Greta - Azarcon and Similar Mexican Folk Remedies"
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.
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.
Guidance:
Districts may 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.
Product Description:
Mexican Folk remedies such as Azoque, Greta, Azarcon, and other similar products
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)]" OASIS Charge Code - UNAPPROVED and the labeling fails to bear adequate directions for use for its intended purpose [Misbranded, Section 502(f)(1)]."
OASIS Charge COde - DIRECTIONS
OASIS Charge COde - DIRECTIONS
Countries
MEXICO
(66 V - - 99) Miscellaneous Patent Medicines, Etc.
Notes:Mexian Folk remedies such as Azoque; Greta; Azarcon; and other similar products
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