Archive for June 30th, 2011

Valproate Products: Drug Safety Communicaton – Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)

Benefits and risks of valproate sodium and related products should be carefully weighed when prescribing these drugs to women of childbearing age.

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FDA: New York dietary supplement manufacturer enters into consent decree

The U.S. Food and Drug Administration has announced that Howard Sousa, doing business as the Artery Health Institute LLC, and DeSousa LLC, in New York, N.Y., has signed a consent decree of permanent injunction. The consent decree prohibits Sousa from distributing products with claims in the labeling to cure, treat, mitigate or prevent diseases.

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Tylenol Extra Strength Caplets, 225 count bottles: Recall – Uncharacteristic Odor

One lot recalled due to the presence of trace amounts of a 2,4,6-tribromoanisole (TBA), which has been associated with temporary and non-serious gastrointestinal symptoms.

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