Drug recall
Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets…
FDA recall event 83848 · Class II · Aurobindo Pharma USA Inc.
Key facts
| Event ID | 83848 |
|---|---|
| Recall numbers | D-0143-2020 |
| Recalling firm | Aurobindo Pharma USA Inc. |
| Product type | Drugs |
| Products | Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness. |
| Initiation date | Sep 19, 2019 |
| Report date | Oct 23, 2019 |
| Termination date | Apr 4, 2023 |
| City | East Windsor |
| State | NJ |
| Country | United States |
| FEI number | 3014213061 |
At a glance
- 1–9 Products in this recall
- None 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: