Drug 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
D-1430-2015
Product summary
- Event
- Event 71830
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,767 bottles
- Official record key
drug-enforcement:D-1430-2015
Official wording
Reason: 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.
Code information: Lot #: F0002, Exp 12/2016
Distribution pattern: NJ - site for distributor
Derived failure modes
-
Potency or specification failure
out of specification