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Anvisa prohibits trade in products with irregularities

22/10/2012

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

 

 



On Thursday (18/10), the National Health Surveillance Agency (ANVISA) published in the Official Gazette, suspension, disqualification and precautionary voluntary recall of products with irregularities.

The suspension lasts the time needed to stabilize the product by the Agency and is effective immediately upon publication in the Official Gazette of the measure. People who have already purchased some of the lots or suspended products should discontinue use.

See the products that were suspended in the table below:
 
 
Suspension of production, distribution and trade, RE No. 4444 across the country. All products subject to sanitary surveillance. Dental Shop Dental Supplies Ltda.
 
The company has no Operating Permit in Anvisa.
 
Suspension of the distribution, sale and use RE 4445 across the country.
 
All products subject to sanitary surveillance.
 
House Orthopedics Hospital Ltda.
 
The company has not released the Operating Agency.
 
Suspension of the distribution, sale and use RE 4446 across the country. All products subject to sanitary surveillance. Artifacts CDS Plastics Ltda.
 
The company has not released the runs in Anvisa.
4447 RE precautionary ban nationwide.
  
 
Lot 0121 Product Alcohol Antiseptic Gel for hands-Allgel. Jalles Machado S / A.
 
The product had unsatisfactory results for tests Determination of pH-pure product and 1% solution.
4448 RE precautionary ban nationwide.
 
 
Lot 0940611016 product Smoothing Step 2.2 Calcium Hydroxide Fine Portier 1kg. Concepcion Cortez Chacon Tonin.
 
The product had unsatisfactory result in the assay of calcium hydroxide content.
 
Suspension of the distribution, sale and use RE 4449 across the country.
 
 
All products under sanitary surveillance.
 
 
Ortcom Trade Material Hospital Medical Ltda.
 
The company has no Operating Permit in Anvisa.
 
Suspension of the distribution, sale and use RE 4450 across the country.
 
 
All products under sanitary surveillance.
 
 
Dental One company, corporate Marilia Vanusa dos Santos Pereira.
 
The company has no Operating Permit in Anvisa.
 
Voluntary Withdrawal RE 4451 across the country. Lots G0461 H0101-1 and the product Typhoid Vaccine Polysaccharide. Sanofi-Aventis Pharma Ltda.
 
In prefilled syringes and frascosampolas batches cited, there was little amount of antigen.
 
Seizure and destruction RE 4452 across the country.
 
 
All units of the product Cialis 20mg, 20 tablets blister, whose labeling the following inscription intaglio "EXP1228014." Eli Lilly of Brazil Ltda.
 
The units containing the inscription cited were fake.
 
Suspension of the distribution, sale and use RE 4453 across the country. Radiological health products set TD500HF-C and Generator Set High Frequency X-Ray TD500HF. Techno Design Industria e Comercio Ltda.
 
The products were adulterated manufacture date for 2008. But were manufactured in 2011 when the company was without Operating Permit.



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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