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Wyeth recalls children's medicines over wrong dosage cup

Wyeth has voluntarily recalled its Robitussin and Dimetapp cough, cold and chest congestion medicine in the US for children aged between two and five years.

Wyeth has voluntarily recalled its Robitussin and Dimetapp cough, cold and chest congestion medicine in the US for children aged between two and five years.

The US-based pharmaceutical company will replace the current marketed products in order to introduce another dosing cup with a half-teaspoon mark, which is the recommended dose for children from two years of age to under six.

The new products will be put on the market with the same medicine content and the new cup from early November 2007. However, replacing the million lots in the market at this point could take several months. Wyeth has advised parents not to use the existing products for their children, but to wait until the product contains the new half-teaspoon cup in the packaging.

In the US, there have recently been voluntary recalls of cough and cold childrenπs medicines from manufacturers because there were cases of childrenπs deaths caused by incorrect dosage.

The deaths were caused by products containing specific decongestants, such as pseudoephedrine, phenylephrine or ephedrine, as well as antihistamines, such as diphenhydramine, brompheniramine or chlorpheniramine.

Two weeks ago, advisory panels recommended to the FDA to ban cough and cold medication marketed for children under six years of age. The FDA usually follows its experts' recommendations, but a decision has yet to be made.

30th September 2008

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