Drug product
Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.
D-0395-2015
Product summary
- Event
- Event 70522
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42 bottles
- Official record key
drug-enforcement:D-0395-2015
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: 2020E141, Exp 07/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications