Novartis Pharmaceuticals Corp. recalls Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LL…

Recall date

July 28, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1430-2015

FDA classification

Class III

Brand / firm

Novartis Pharmaceuticals Corp.

Sold / distributed

NJ - site for distributor

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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