Drug recall
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate…
FDA recall event 71594 · Class II · Teva Pharmaceuticals USA
Key facts
| Event ID | 71594 |
|---|---|
| Recall numbers | D-1283-2015 |
| Recalling firm | Teva Pharmaceuticals USA |
| Product type | Drugs |
| Products | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: out of specification for unknown impurity |
| Initiation date | Jun 24, 2015 |
| Report date | Aug 12, 2015 |
| Termination date | Aug 17, 2016 |
| City | Horsham |
| State | PA |
| Country | United States |
| FEI number | 3004442422 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: