FDA recall D-1430-2015

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

Reason for recall

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.

Distribution

NJ - site for distributor

Key facts

Status

Terminated

Initiation date

2015-07-28

Report date

2015-09-23

Termination date

2017-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Suffern, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1430-2015