Drug recall
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by…
FDA recall event 73679 · Class II · Impax Laboratories, Inc.
Key facts
| Event ID | 73679 |
|---|---|
| Recall numbers | D-0825-2016, D-0826-2016 |
| Recalling firm | Impax Laboratories, Inc. |
| Product type | Drugs |
| Products | Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10, Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Initiation date | Mar 14, 2016 |
| Report date | Apr 27, 2016 |
| Termination date | Feb 9, 2018 |
| City | Middlesex |
| State | NJ |
| Country | United States |
| FEI number | 3002535019 |
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: