FDA-Drug2015-09-23Class III
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Novartis Pharmaceuticals Corp.
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.
Sold states
NJ - site for distributor
Affected count
10,767 bottles
Manufactured in
25 Old Mill Rd, Suffern, NY, United States
Products
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1430-2015Don't want to check this manually?
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