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ANVISA suspends sale and use of two drugs

05/02/2013

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



 


Biozatin problems presented test injectability. Label imipenem / cilastin contain irregularities. Both are from Novafarma

Agency also prohibits the distribution and marketing of other products irregular

ANVISA announced Tuesday the suspension of the marketing and use of various medications Playback internet
 
BRASILIA - ANVISA determined, on Tuesday, the suspension of distribution, sale and use throughout the country lots of two products manufactured by the company Novafarma Pharmaceutical Industry. Lots of Biozatin 11004884 and 1100451 (benzathine penicillin), powder for injectable suspension, showed unsatisfactory results in test injectability. Already lots with numbers between 1070040 to 1070094 of the drug imipenem / cilastin generic sodium (500 mg + 500 mg) were suspended to contain irregularities in the product labeling.

The regulator also ordered the suspension of manufacturing and seizure of products from other companies that had irregular. The suspension of one or all lots of these products is final and is effective immediately.

The intimate soap Dyn Milk Knut, of Point 9 Cosmésticos had manufacturing, dissemination, distribution, sale and use suspended for not being registered with ANVISA.

All products for health Direx Brazil are with import, marketing and use suspended for noncompliance with the Rules of Good Manufacturing Practices for Health Products

The products subject to sanitary surveillance of Commercial Zakin also with the manufacture, distribution, sale and use by not having a suspended registration and authorization of the ANVISA.

Already the product under sanitary surveillance Labs Fruit of the Earth are subject to seizure and destruction, as well as the prohibition of disclosure across the country, because the company has no license to operate.

People who have already purchased some of the items subject to seizure or suspended should discontinue use immediately.

In a statement, says Novafarma is taking appropriate action with ANVISA for the collection of the lots in accordance with Brazilian regulations.
He adds that all your medicines are manufactured according to the standards of Good Manufacturing Practices and Control (CBPFC), following ISO 9001 quality standards and standard operating procedures for maintaining the quality and safety of their products and processes.

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Source: The Globe

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

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