A medication used to treat narcolepsy and attention deficit hyperactivity (ADHD) in adults and children is being recalled by the manufacturer because some of the tablets exceed weight requirements, which could make them super-potent and could pose a risk to consumers who take them.
The recall, announced by the Food and Drug Administration (FDA) includes Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (mixed salts of a single entity amphetamine product) 20 mg tablets, 100-count bottles, lot number 311756. The recalled lot, made by Barr Laboratories, Inc., was distributed between June 6, 2009 and June 16, 2009.
Potential adverse reactions to 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. To date, Barr Laboratories has not received any adverse events for the product.
The products can be identified as an oval peach colored tablet with b/973 on one side and 2/0 on the other. Consumers and pharmacists who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor. Wholesalers and retailers should cease distribution and examine their inventory immediately.
Consumers with questions concerning the recalled lot may call 888-742-5578 between 8 a.m. and 8 p.m., EDT Monday through Friday. Adverse reactions experienced with the use of this drug should be reported to the FDA’s MedWatch Program.