Drug recall
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent…
FDA recall event 63926 · Class II · Amedra Pharmaceuticals LLC
Key facts
| Event ID | 63926 |
|---|---|
| Recall numbers | D-171-2013, D-172-2013, D-173-2013 |
| Recalling firm | Amedra Pharmaceuticals LLC |
| Product type | Drugs |
| Products | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09, Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09, Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. |
| Initiation date | Dec 4, 2012 |
| Report date | Mar 6, 2013 |
| Termination date | Mar 21, 2014 |
| City | Horsham |
| State | PA |
| Country | United States |
| FEI number | 3009530344 |
At a glance
- 1–9 Products in this recall
- 1–9 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: