August 17, 2009
Dextroamphetamine, amphetamine 20mg tablets recalledBarr Laboratories has issued a voluntary recall of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (mixed salts of a single entity amphetamine product) 20mg tablets, 100 count bottles, Lot# 311756, distributed between June 11, 2009 and June 16, 2009. The product is being recalled because the affected lot may contain some tablets exceeding weight requirements, which may lead to super-potent tablets. Potentially clinically significant adverse reactions to a supratherapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions such as: palpitations, tachycardia, hypertension, headache, tremor, tic, dyskinesia, dizziness, blurred vision, sweating, insomnia, agitation, euphoria, mania, anxiety, restlessness, nausea, diarrhea, constipation, dry mouth, and decreased appetite.
Patients who have this product in their possession should stop using it immediately and return it to their pharmacy.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177434.htm