Class III
Terminated
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
- Company
- Novartis Pharmaceuticals Corp.
- Recall Initiated
- July 28, 2015
- Posted
- September 23, 2015
- Recall Number
- D-1430-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10,767 bottles
- Firm Location
- Suffern, NY, United States
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
Lot / Code Info
Lot #: F0002, Exp 12/2016
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