Drug product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
D-190-2013
Product summary
- Event
- Event 64506
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,264 Bottles
- Official record key
drug-enforcement:D-190-2013
Official wording
Reason: Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Code information: Lot #: 50077231
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification