Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540

Recall Number: D-1430-2015

Firm: Novartis Pharmaceuticals Corp.

Classification: Class III

Status: Terminated

Report Date: 20150923

Initiation Date: 20150728

Termination Date: 20170510

Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.

Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540