Drug product
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
D-173-2013
Product summary
- Event
- Event 63926
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,968 bottles
- Official record key
drug-enforcement:D-173-2013
Official wording
Reason: Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Code information: Lot 220843, exp 11/30/2013
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications