FDA Drug recall D-1448-2016
Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ…
- FDA Drug
- Class II
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class II recall of Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ… by Actavis, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1448-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-11 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis |
| Distribution | US |
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
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 45963-303-09 |
|---|---|
| ndc | 45963-304-09 |
| ndc | 45963-305-09 |
| code_info | Lot #: 3803J141, Exp. 7/2016 |
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-1448-2016%22
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