Prohibit the sale and use of an anti-cancer drug and a brand of olive oil

According to the National Cancer Institute of the United States, Keytruda is a drug used to "treat advanced renal cell carcinoma (a type of kidney cancer) that has not been treated yet". It is also used in certain types of lung cancer, cervical cancer, stomach cancer, Hodgkin lymphoma and melanoma, among others.

The resolution of the ANMAT came after an inspection of the Psicofarm pharmacy, which confirmed the existence of products whose origin was unknown. Some of these units were found at the Chaco Ministry of Public Health, without a "traceability label" or with "security seals of secondary cases […] violated. "The Chaco State Office stated that they had been acquired from Psicofarm and TM.

After comparison with other batches, "the existence of counterfeit products" and differences in the contained solution were found: "the original solution is transparent and translucent, while the duplicated samples contain an opalescent solution with suspended particles ".

Already at the beginning of August, the Administration had issued an alert concerning the counterfeit units of this product (visible in the secondary cases violated and other peculiarities of the package) and had recommended not to apply it. Similarly, the TM pharmacy has already repudiated the counterfeit on this occasion.

According to the Directorate of Health Product Surveillance (DVS), the "sterility requirement" of the drug Keytruda is "essential" and the product "should be stored between 2 ° and 8 ° C, should not be frozen and should be protected from light. "

Prohibited oil

ANMAT has banned the marketing of olive oil. Through the provision 6765/2019, it has been activated against the "Premium olive oil, brand Olivares del Norte, RPPA No. 02-525904, prepared and divided by Sineto SRL, Marble No. 45 , Lanús, pcia. of Buenos Aires, RPE No. 836.568C2009 ", as indicated in the provision 6765/2019.

The company does not have a product and establishment authorization, which is "falsely labeled by entering a non-existing EPS and an RNPA belonging to another product, which turns out to be illegal in result".

In addition, the agency banned the use, marketing and distribution in the country of "all measures of the medical product marked" FILES K / Ref. 063 CCCord / stainless / UNITED DENTAL, U.S.A. "".

These are files used in dentistry in the endodontic procedure. According to the 6771 provision, the ban is due to the fact that it is not registered in the register of producers and products of medical technology.

In turn, by the provision 6768/2019, it is prohibited "throughout the national territory to use and market all lots of all Baigrin brand products whose labels indicate that the product is manufactured and distributed by Tresher, without data from RNE or RNPUD ".

This case originates from an inspection of Tresher, in Paso del Rey, "of the manufacturer and distributor of Baigrin's water stabilizer for swimming pools".

The investigation verified that Tresher "does not have a national register of national establishments before ANMAT and that its products are therefore not registered with this administration, and that it is impossible to reliably determine which company is responsible for the preparation and marketing of the product. " product ".

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