ETHEX Corporation announced Oct. 16 that it is voluntarily recalling lots of Dextroamphetamine Sulfate 5 mg tables due to oversized pills that may contain as much as twice the labeled amount of its active ingredient, according to a press release issued by the U.S. Food and Drug Administration (FDA). The recalled lots were distributed under the ETHEX label between January 2007 and May 2008.

ETHEX chose to voluntarily recall the product after discovering a limited number of oversized tablets in lots that had not yet been distributed. The company has not received any reports of oversized tablets nor any unexpected side effects or injury related to the product.

Dextroamphetamine Sulfate is generally prescribed for narcolepsy and attention deficit disorder with hyperactivity. Taking a higher than expected dose of the medication can result in adverse side effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset and dry mouth.

Last April, in a similar incident, US generic pharmaceutical group Actavis Totowa LLC recalled batches of Digitek, commonly used in the treatment of various heart conditions, after concerns that tablets contained twice the active ingredient. Taking more than the safe level of Digitek can lead to Digitek toxicity, which can result in illness, cardiac instability and death.

Multiple companies in the US produce and market generic versions of Dextroamphetamine Sulfate 5 mg. Consumers and caregivers are encouraged to check their prescriptions to determine the source. In the interim, customers and their caregivers should not use any Dextroamphetamine Sulfate tables that appear to be oversized.

Customers with questions about the recall or their specific medication should contact ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or via email to: customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.



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