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Você está aqui:Home » EDITORIAS » Gerais » Anvisa proíbe uso de Água Rabelo em todo o Brasil

Anvisa proíbe uso de Água Rabelo em todo o Brasil

Uma resolução da Agência Nacional de Vigilância Sanitária (Anvisa), publicada no Diário Oficial da União, no último dia 2, está proibindo a distribuição, comercialização e uso de todos os lotes do fitoterápico Água Rabelo, fabricados desde 2011 pelo Laboratório Rabelo, sediado em Cabedelo.
A decisão se deu depois que uma inspeção, realizada em abril deste ano, constatou que a fórmula dos produtos estava diferente daquela registrada na Anvisa. Para o órgão, que cita o artigo 7º da Lei 6.360/1976, isso representa risco de efeitos nocivos à saúde humana, classificando a ação como de interesse sanitário. A Agência Estadual de Vigilância Sanitária (Agevisa) disse estar emitindo alertas sanitários aos órgãos municipais, para fiscalizar se a determinação está sendo cumprida.
A resolução – de nº 2.736, de 31 de julho de 2013 – vale para todo o território nacional e determina ainda o recolhimento do estoque de Água Rabelo existente no mercado. A inspeção contou com a análise inicial de documentos referentes a três lotes, que já apresentavam incongruência com o registro, e por uma avaliação do produto pela Coordenação de Fitoterápicos e Dinamizados da Anvisa, que igualmente confirmou a alteração.

O diretor-geral da Agevisa-PB, Jailson Vilberto de Sousa e Silva, explicou que a própria empresa é responsável de retirar os produtos do mercado e, caso desobedeça, está sujeito a punições, que variam desde uma advertência e outras sanções administrativas até uma multa. “Estamos emitindo, desde o dia da publicação da Anvisa, alertas sanitários para todas as vigilâncias sanitárias dos municípios, divulgando a resolução. Vamos continuar com as fiscalizações de rotina”, afirmou.

Laboratório promete volta ao mercado

O diretor comercial do Laboratório Rabelo, Werner Braun, explicou que, há cerca de 60 dias, a empresa recebeu a visita da Anvisa e foi informada de que precisaria adequar algumas documentações, em função do tempo do produto. “Na realidade, produtos antigos têm que se adequar à nova legislação da Anvisa, e foi esse o ponto. Eles pediram que fosse feita uma espécie de atualização, porque existe uma mutação na própria planta. Uma aroeira ou um eucalipto, por exemplo, elas sofrem mutação para novas espécies. É justamente essa adequação que estamos fazendo, de caráter documental”, disse, informando que já não há mais produtos no mercado.

Werner garantiu também que o Laboratório Rabelo vai entregar, até o dia 20 deste mês, a documentação necessária, para que a Água Rabelo seja inspecionada novamente e volte ao mercado a partir do dia 10 de setembro. O diretor assegurou, por fim, que os consumidores não devem temer, porque, segundo ele, o recolhimento determinado pela Anvisa é estritamente documental. “É importante saber que existem três níveis de recolhimento. O nível 1 e 2 é porque o produto está com inconformidade para o consumidor. O nível 3, que é o nosso, não tem nenhuma inconformidade, é apenas documental. A Água Rabelo não oferece risco à saúde”, enfatizou. O laboratório disponibiliza um telefone para dúvidas: 0800 281 3737.

Para que serve?

A Água Rabelo é um medicamento fitoterápico composto, que apresenta como componentes plantas medicinais como a aroeira, a hortelã e o eucalipto. Por isso, segundo o laboratório que a fabrica, o medicamento é indicado para inúmeros fins, entre eles os de uso externo ou tópico – cortes, ferimentos, contusões, queimaduras, hemorróidas, aftas, doenças de pele, picadas de insetos, acne, limpeza de pele, higiene da boca, nariz e garganta, gengivite, amidalite, faringite, irritação da pele após barbear, inflamações uterinas -e de uso interno ou oral – gases estomacais e intestinais, acidez estomacal, enjôo, má digestão e cólicas intestinais.

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