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U.S. Department of Health and Human Services

Safety

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Dextroamphetamine Sulfate 5mg Tablets

Audience: Pharmacists, other healthcare professionals, patients

[Posted 10/16/2008] Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions.

[October 15, 2008 - Press Release - Ethex]