Agência Nacional de Vigilância Sanitária suspende os antibióticos amoxicilina e rifamicina do laboratório EMS

anvisa

A Anvisa anunciou nesta quarta-feira (4) a suspensão de dois antibióticos da farmacêutica EMS. Um deles é a amoxicilina + clavulanato de potássio 50 mg/ml + 12,5 mg/ml pó para suspensão oral. O outro é a rifamicina 10 mg/ml solução tópica spray. No caso da amoxicilina, a suspensão se aplica à distribuição e venda de todos os lotes do produto fabricados a partir de fevereiro de 2013. Segundo a determinação da agência, o produto deve parar de ser fabricado e os estoques restantes no mercado devem ser recolhidos pela empresa.

A suspensão foi determinada porque o produto estava sendo fabricado com excipiente diferente do que foi aprovado pela Anvisa. Os excipientes são substâncias presentes nos medicamentos para dar características como volume, forma e consistência ao produto. Além disso, um insumo farmacêutico usado no medicamento estava sendo sintetizado de forma diferente do que consta no registro. “As duas mudanças podem levar a alterações no resultado final do produto”, diz nota divulgada pela agência.

No caso da rifamicina, a suspensão ocorreu porque a empresa aumentou o tamanho do lote em 10 vezes sem a aprovação da Anvisa. Em nota, a EMS afirma que “já está tomando todas as providências necessárias”. “A empresa ressalta que sempre manteve os mais rigorosos padrões de produção e qualidade em seus medicamentos”, acrescentou à farmacêutica, que colocou à disposição dos consumidores o telefone 0800-191914 (de segunda a sexta-feira, das 9h às 17h).

Fontes: G1 e Anvisa



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