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Anvisa suspends batch of medicine

08.25.2015

This article was translated by an automatic translation system, and was therefore not reviewed by people.

 

 

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Anvisa determined the precautionary ban the lot 0000081766 of the drug Sodium Chloride A 0.9%, 1000 mL, valid until 9/12 // 2015 manufactured by Halex Istar Pharmaceutical Industry Ltda. 

 

The agency took this step considering the fiscal analysis report issued by the National Institute of Quality Control in Health (INCQS), who presented unsatisfactory results in sterility test because it was verified the presence of Bacillus megaterium for the batch quoted.

 

The action taken by Anvisa in relation to the lot 0000081766 Sodium Chloride Halex Istar brand is in Resolution 2,409 / 2015 published on Tuesday (25/8) in the Official Gazette (DOU).

 

Source: Anvisa

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This article was translated by an automatic translation system, and was therefore not reviewed by people.

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