FDA Drug recall D-190-2013
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules,…
- FDA Drug
- Class III
- terminated
- Published 2013-03-13
On 2013-03-13 the FDA classified a Class III recall of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules,… by Actavis Elizabeth, citing failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-190-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-13 |
| Published | 2013-03-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis Elizabeth |
| Distribution | US |
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.
Reason
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Identifiers
| ndc | 0228-3062-11 |
|---|---|
| ndc | 0228-3059-11 |
| ndc | 0228-3063-11 |
| ndc | 0228-3060-11 |
| ndc | 0228-3064-11 |
| ndc | 0228-3061-11 |
| code_info | Lot #: 50077231 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-190-2013%22
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