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 64720-327-09
D-171-2013
Product summary
- Event
- Event 63926
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,176 bottles
- Official record key
drug-enforcement:D-171-2013
Official wording
Reason: Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Code information: Lot 238316, exp 01/31/2014
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications