Clipping of news on Brazilian Culture, Law and Citizenship
10/08/2012
This article was translated by an automatic translation system, and was therefore not reviewed by people.
The National Health Surveillance Agency (ANVISA) warning about quality deviation detected in lots G0461-1 (Fab.19/09/2010 and Exp 08/31/2013) and H0101-2 (Fab and 02/03/2011 Val 2/21/2014) Polysaccharide Typhoid Vaccine, internationally known as Typhim Vi. The vaccine is manufactured and distributed by Sanofi-Aventis Pharma Ltda.
According to the press release sent by the company voluntary recall, the two batches of the product were identified with a lower amount of antigen in relation to specification. The batches with quality deviation are in the form of prefilled syringes and vials of 20 doses.
Anvisa will publish next week a resolution to suspend distribution, sale and use of drug units that have unconformities.
Source: ANVISA
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This article was translated by an automatic translation system, and was therefore not reviewed by people.