Clipping of news on Brazilian Culture, Law and Citizenship
28/11/2012
This article was translated by an automatic translation system, and was therefore not reviewed by people.
The National Health Surveillance Agency (ANVISA) published in the Official Gazette (DOU) on Tuesday (27/11), the suspension of the distribution, sale and use throughout the country, lots 12030260, 12030261, 12030262 , 12030263, 12030271, 12040407, 12040408, 12040413, 12040414, 12040415, 12040446, 12040447, 12040448, 12050461, 12050462, 12050463, 12050464, 12050465, 12050466, 12060585, 12060586, 12060587, 12060588, 12060589, 12060590, 12060591, 12060592, 12060593 , 12060594, 12060595 and 12060596 of the medicine hydrochlorothiazide 25 mg tablets, manufactured by the Institute of drug Technology-Farmanguinhos. The medication is a diuretic used in the treatment of hypertension.
The lots were suspended because there is no data proving the safety and efficacy of the product manufactured differently from assessed and registered in ANVISA. It was found that the particle size of the product (due to the milling) can affect product performance and interfere with stability, dissolution, and other requirements.
The suspension is final and valley from the disclosure of the measure in the Official Gazette People who have already purchased some of the lots should discontinue use suspended.
Source: ANVISA
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This article was translated by an automatic translation system, and was therefore not reviewed by people.