Recall | Barr Laboratories, Inc. Recalls Dextroamphetamine & Amphetamine (20mg Tablets, Lot number 311756)

Recall Alert:  Dextroamphetamine & Amphetamine Recalled By Barr Laboratories, Inc.

On August 13, 2009, the FDA issued a press release and notice of recall on its website anouncing that Barr Laboratories, Inc. was initiating 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 number 311756.  

The drug 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.

According to the FDA, the product can be uniquely 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 06/11/09 and 06/16/09.  Only lot 311756 is affected by this recall. 

Customers and patients who have this lot in their possession were instructed by the FDA to cease using the product and return it to their pharmacy/distributor.  Barr Laboratories has not received any adverse events for this product lot.  The FDA has been apprised of this action.