FDA Drug recall D-1094-2014
Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts…
- FDA Drug
- Class II
- terminated
- Published 2014-03-12
On 2014-03-12 the FDA classified a Class II recall of Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts… by Teva Pharmaceuticals Usa, citing CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved mater….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1094-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-24 |
| Published | 2014-03-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.
Reason
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
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 # 34017575A, Exp. 10/16. |
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-1094-2014%22
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