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Anvisa Seizes Counterfeit Batches of Mounjaro

The agency has banned the sale and use of counterfeit batches of the drug and unregistered products sold as Mounjaro

The Brazilian Health Regulatory Agency (Anvisa) ordered on Friday (10) the seizure and ban on the sale, distribution, and use of counterfeit batches of the drug Mounjaro. The measure was published in the Federal Official Gazette (DOU) after the manufacturer identified products with characteristics different from the originals.

According to the agency, the following lots were seized: D880403, MJR 257, and D854901 of the 15 mg strength, and lot 855044 of the 10 mg strength. According to the manufacturer Eli Lilly, which holds the drug’s marketing authorization, two of the batches are not even recognized by the company, while others had incompatible serial numbers, packaging different from the original, and even a spelling error on the packaging—with the word “soluction” instead of “solution”—which confirmed the counterfeiting.

Anvisa clarified that, in the cases of lots D880403 and D854901, the measure applies only to the counterfeit units identified on the market and does not affect the authentic products manufactured by the company.

In the same resolution, the agency also ordered the seizure and prohibited the manufacture, sale, distribution, advertising, and use of all products manufactured by PSM Pennaforte Produtos Naturais Ltda. Among them are items marketed as “Mounjaro Natumix” and “Ozempic Natural Natumix,” in addition to other products.

Source: https://sbtnews.sbt.com.br/noticia/brasil/anvisa-apreende-lotes-falsificados-de-mounjaro