Novartis issues voluntary recall of ADHD drug manufactured in Georgia

Novartis ($NVS) 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."

The drugs being recalled were 100-tablet bottles from lot number F0002 with an expiration date of December 2016.

In May, Recro Pharma ($REPH) picked up the Gainesville plant from Alkermes ($ALKS) for $50 million in cash and up to $120 million in milestones payments, as well as royalties, to get the DEA-approved manufacturing facility and a number of pain drugs. The deal also got the Ireland-based Alkermes out of the CMO business.

- check out the FDA report