Clipping of news on Brazilian Culture, Law and Citizenship
12/06/2012
This article was translated by an automatic translation system, and was therefore not reviewed by people.
The National Health Surveillance Agency (ANVISA) published on Monday (11/6) in the Official Gazette (DOU), a precautionary ban, throughout the country, lots 227 and 228 of the drug Ranitidine Hydrochloride 150mg, Ranidine brand, with expiration date to 08/2012. The medications are manufactured by the company Green Chemistry, Pharmaceutical Pharma Inc. and the two lots were banned for suspected quality deviations.
It is also prohibited throughout the country, the sale of lots 100 378 (manufactured in 03/2010 and valid until 03/2013) and 101,364 (manufactured in 09/2010 and valid until 09/2013) of the product aluminum hydroxide 60mg/ml oral suspension, manufactured by Industrial Mariol. The product had the use, sale and distribution suspended for having unsatisfactory result in testing aspect.
REBLAS
Ecolyzer Laboratories Ltd. The company had its license suspended by ANVISA in REBLAS due to inconsistencies in the Evaluation Report and the company's failure to comply with general requirements for testing and calibration laboratories and Good Laboratory Practice (GLP) of the Organisation for Economic Cooperation and Development (OECD / INMETRO).
Anvisa clarifies that companies with ongoing processes for product registration in the Agency and other petitions, presenting reports of the Laboratory Ecolyzer should carry out further analyzes in laboratories or recognized by the REBLAS Inmetro.
Press / Anvisa
Source: ANVISA
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This article was translated by an automatic translation system, and was therefore not reviewed by people.