Clipping of news on Brazilian Culture, Law and Citizenship
24/10/2012
This article was translated by an automatic translation system, and was therefore not reviewed by people.
Hydrochlorothiazide indicated for high blood pressure, manufacturing has changed.
Honey with herbs and herbal-Pro had no authorization from the agency.
The National Health Surveillance Agency (ANVISA) has suspended the use and sale of 30 lots of the drug diuretic Hydrochlorothiazide, used against hypertension. The decision was published in the Official Gazette on Wednesday (24).
Anvisa made an inspection at the Institute of Drug Technology, manufacturer of the drug, between 23 and 26 July, and found a change in the manufacturing process of tablets of 25 mg. The products had passed through a stage of milling the active ingredient without permission of the agency.
According to Anvisa, no data proving the safety and efficacy of diuretic manufactured differently from assessed and recorded. Furthermore, because of milling, the particle size of the tablet can affect product performance and interfere with stability, dissolution, and other requirements and goals.
The 30 lots are suspended: 12030260, 12030261, 12030262, 12030263, 12040407, 12040408, 12040413, 12040414, 12040415, 12040446, 12040447, 12040448, 12040461, 12040462, 12040463, 12040464, 12040465, 12040466, 12060585, 12060586, 12060587, 12060588, 12060589, 12060590, 12060591, 12060592, 12060593, 12060594, 12060595 and 12060596.
Twelve of them were banned by the Health Surveillance Center of the State Department of Health of Rio de Janeiro. The rest must be collected from the market, said ANVISA.
Products with Herbs
The agency also ordered the seizure and destruction throughout the country, Mel herbal product with therapeutic indication for asthma. The reason is that the company Facon - Manufacture and sale of cosmetics and natural Ltda, based in Iguatu (EC), had no license to operate health.
Another product is suspended by ANVISA Pro-herbs, manufactured in Ipatinga (MG), because the company responsible also not be allowed to be active.
Source: ANVISA
Our news are removed entirely from the sites of our partners. For this reason, we can not change their content even in cases of typos.
This article was translated by an automatic translation system, and was therefore not reviewed by people.