FDA Drug recall D-1283-2015
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts o…
- FDA Drug
- Class II
- terminated
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class II recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts o… by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: out of specification for unknown impurity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1283-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-24 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02
Reason
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Identifiers
| ndc | 0555-0971-02 |
|---|---|
| ndc | 0555-0775-02 |
| ndc | 0555-0972-02 |
| ndc | 0555-0776-02 |
| ndc | 0555-0777-02 |
| ndc | 0555-0973-02 |
| ndc | 0555-0974-02 |
| code_info | Lot #: 34015862A, Exp. Date 6/2016 Lot #: 34016376A, Exp. Date 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-1283-2015%22
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