Novartis has issued a voluntary recall of more than 10,000 bottles of a drug used to treat attention deficit hyperactivity disorder (ADHD) that were manufactured at a plant in Georgia.
According to a FDA enforcement report, the Class III recall was for 10,767 bottles of prescription-only 10-milligram dexmethylphenidate HCI extended-release capsules that were manufactured by Alkermes Gainesville in Gainesville, GA.
The reason cited for the recall was an "out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing."
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1430-2015&w=09232015&lang=eng
