Drug product
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
D-0826-2016
Product summary
- Event
- Event 73679
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,936 bottles
- Official record key
drug-enforcement:D-0826-2016
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: 112565, Exp 03/17; 113458, Exp 08/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications