Barr Laboratories Inc initiated a voluntary recall of a generic amphetamine medication used to treat narcolepsy. The voluntary recall is for 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. Only this lot is affected by the recall.
According to the US Food and Drug Administration’s Web site, “The product identified 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. The company has not received any adverse events for this product lot.
The product can be identified as an oval peach-colored tablet, debossed with b/973 on one side and 2/0 on the other side. Barr distributed the affected lot between June 11 and June 16, 2009.
Customers 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 can contact Barr Laboratories at (888) 742-5578 from 8 am to 8 pm EDT Monday-Friday.
Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at (800) FDA-1088.