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The National Health Surveillance Agency (ANVISA) suspended on Friday (1st), distribution and trading of 2,864,017 Land of the drug ampicillin sodium 500 mg, powder injection DPC/50 +50, 2 mL diluent vial. A decisão foi publicada no Diário Oficial da União. According to ANVISA, a batch of the drug, manufactured by Laboratorio Teuto Brasileiro Ltda, was closed as a precaution in November last year on suspicion of quality deviation. The ban is the first precautionary measure that adopts regulatory agency when there is suspected diversion.
The award rebuttal analysis confirmed that the batch, production date 3/2011 and valid until 3/2013, showed unsatisfactory results when testing ampicillin sodium content, the agency said in a statement.
According to ANVISA, the company behind the product should collect all inventory of the antibiotic on the market. The suspension is final and valley throughout the country.
Guidance for people who have already bought the product batch is suspended discontinue use of the medication.
Palavras-chave: Antibiotic
Ampicillin sodium 500 milligrams
National Health Surveillance Agency
Anvisa
Official Gazette
Lot
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