Clipping of news on Brazilian Culture, Law and Citizenship
25/1/2010
This article was translated by an automatic translation system, and was therefore not reviewed by people.
(Fonte: Folha Online)
Fonte: Idec
Johnson & Johnson has recalled several products - among them, the Tylenol - on Friday (15) in the United States for the second time in less than a month due to a musty smell that made users get sick.
The company said the recall includes about 500 lots. Johnson & Johnson in Brazil said last night that none of the lots marked on the recall arrived.
The recall includes lots of extras and regular Tylenol, Children's Tylenol, Tylenol eight hours, Tylenol Arthritis, Tylenol PM, Motrin for children, Motrin IB, Rolaids Benadryl, Simply Sleep and St. Joseph aspirin. Lots of products sold in North, Central and South America, the United Arab Emirates and Fiji were also included in the recall. However, countries in the Americas were not specified by the company.
In November, the company called for the recall of Tylenol Arthritis pills in November because of the smell - which caused nausea, stomach pain, vomiting and diarrhea. Three weeks ago, the company extended the recall to the Tylenol Arthritis in capsule. About 70 people saw or were nauseous because of the odor.
The way the company handled the recall angered the FDA (Food and Drug Administration), which regulates the federal - they found that the company did not act quickly enough. The FDA said it knew of the problem since early 2008, but there was only a limited research on the subject.
"The company should have acted faster," said Deborah Autor, director of the center of evaluation and research of the FDA. "When something stinks, literally or figuratively, companies must aggressively investigate and take all necessary measures to resolve the problem," he added.
The FDA sent a warning letter to the company for breach of standards of manufacturing and the lack of information and research the problem adequately. Johnson & Johnson has 15 days to respond. The FDA says it wants an explanation of why the problem has not been made public sooner.
This article was translated by an automatic translation system, and was therefore not reviewed by people.