Pharmaceutical Business review

Barr Laboratories Recalls Dextroamphetamine/Amphetamine 20mg Tablets

Barr Laboratories has initiated a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 20mg tablets, 100 count bottles, lot number 311756. The product is being recalled as the company fears the affected lot may contain some tablets exceeding weight requirements, which may lead to super-potent tablets.

Potentially significant adverse reactions to a supratherapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions.

The company said that 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 06/11/09 and 06/16/09. Only lot 311756 is affected by this recall.

Barr has urged the customers who have this lot in their possession to cease using the product and return it to their pharmacy/distributor. Wholesalers and retailers should cease distribution and examine their inventory immediately.