Ethex has voluntarily recalled three lots of dextroamphetamine sulfate 5mg tablets due to the possibility of double-thick tablets which may contain twice the level of active ingredient. At this time, there have been no reports of oversized tablets or unexpected side effects or injuries. However, the existence of double-strength tablets increases the risk of adverse events such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth. The recalled lots were distributed between January 2007 and May 2008.
Dextroamphetamine sulfate is indicated for the treatment of narcolepsy and attention deficit hyperactivity disorder.
For more information call (800) 321-1705 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm110245.htm.