Novartis Pharmaceuticals Corp. recalls Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LL
Recalled September 23, 2015 · FDA recall D-1430-2015 · Novartis Pharmaceuticals
Hazard
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. · FDA Class III
Units
10,767 bottles
Sold at
NJ - site for distributor
Description
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.
Product
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Manufacturer(s)
Novartis Pharmaceuticals Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →