Drug product
Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA NDC 45963-304-09
D-1448-2016
Product summary
- Firm
- Actavis Inc
- Event
- Event 74713
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,062 units
- Official record key
drug-enforcement:D-1448-2016
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: 3803J141, Exp. 7/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications