The National Administration for Drugs, Food and Medical Technology (ANMAT) decided to prohibit the commercialization of a medicine to prevent heart attacks and strokes.
The agency withdrew from the market a batch of clopidogrel Rospaw following detecting “quality deviations”as detailed in an official statement.
“The population is informed that the firm ROSPAW SRL has initiated, at the request of this National Administration, the withdrawal from the market of the product labeled as CLOPIDOGREL ROSPAW / CLOPIDOGREL (Hydrogen Sulfate) 75 MG, coated tablets, hospital presentation for 1000 units, Lot : 073210 – Expiration: 12/2023, Certificate No. 54057”, they detailed.
Is regarding an antithrombotic/antiplatelet productindicated for the prevention of atherothrombotic events (myocardial infarction, cerebrovascular accident and vascular death).
The measure was taken following quality deviations were detected in the identification of related substances.
ANMAT is monitoring the withdrawal from the market and recommends that the community refrain from using the detailed batch of the product.
ANMAT prohibited the sale and distribution of various products and foods, including eight sunflower oils
This week ANMAT prohibited the sale and distribution of various products and food
This Monday, the ANMAT (National Administration of Medicines, Food and Medical Technology) prohibited the preparation and commercialization throughout the country of different products and foods, including a brand of empanada tops, various oils, a baking powder, a Himalayan salt and a product described as “therapeutic”.
The first of the products to be prohibited in any presentation, lot and expiration date was “BIO HEALTH HERB, probiotic dietary supplement, produced by CHICAGO, IL, USA”. As indicated, it “lacked sanitary records of establishment and product”, therefore it was an illegal product.
Also, the “baking powder gluten free without TACC brand PROCAL Cont. Net 50g, Manufactured by: Food Processor, Av. Calle Real 888, Merlo, pcia. de Bs.As, RNE 2906-16162/14, RNPA 4076-4558″ was restricted as a consequence of being “falsely labeled by displaying non-existent registration numbers on its labels”.
ANMAT withdrew a brand of olive oil from the market for being “falsely labeled”
Eight different brands of sunflower oil were impacted by ANMAT’s ban following the entity detected that they “lacked establishment and product records”, at the same time that they presented inconsistencies in the RNE and RNPA numbers on their labels.
In turn, through Provision 423/2023, the control body ordered to stop the production, fractionation and commercialization throughout the Argentine territory of different preserves. Said measure included “Aubergines”, “Aubergines in oil”, RNPA 02-570774, “Stuffed green olives”, RNPA 02-570772, “Green olives”, RNPA 02-570770 and “Chili peppers in vinegar”, RNPA 03001163-5 . All these products belong to the Morando Alimentos brand, Fractionated and Distributed by Olivos del Sur Alimentos SRL, and, as detailed, “lacked sanitary records” and were “falsely labeled by displaying RNE and RNPA numbers on their labels non-existent”, so they turn out to be illegal products.
Something similar happened with a brand of Himalayan salt, fine grain, product of Pakistan, which was banned in any presentation, batch and expiration date as said product was “falsely labeled, misleading and indicated therapeutic properties”. Consequently, it “may not be marketed or sold in the territory of the Republic”, given that “it cannot be reliably and clearly identified as produced, prepared and/or divided in a specific establishment”.
ANMAT also restricted the sale and marketing of the “black maca powdermicropulverized, toasted, Lepidium meyenil”, which clarifies on its label that it is a “100% pure natural supplement”. However, the agency pointed out that “it does not include mandatory information on the label, it is misleading and indicates therapeutic properties “, thus being classified as an illegal product.
Finally, the last product prohibited by the control entity were “tapas for empanadas, creoles for frying, Sol Dorado brand. Manufactured and distributed by EL SOL DORADO, RNE 02-583732, Municipal Hall: 4074-2306-2013”.
As explained by the agency, said prohibition arises from “not being able to guarantee its traceability, its manufacturing conditions, its quality with adequate levels of control under the conditions established by current regulations and its safety”, at the same time that “it displayed on its labels non-existent registration numbers”.
RB/fl
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