FDA Drug recall D-0050-2015
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bo…
- FDA Drug
- Class II
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class II recall of DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bo… by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0050-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-08 |
| Published | 2014-11-05 |
| 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, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.
Reason
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
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 #: 34016373A, Expiry: 7/2016; Lot #: 34016377A, Expiry: 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-0050-2015%22
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