Amedra Pharmaceuticals LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-385-2014 | Class II | Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, | October 7, 2013 |
| D-173-2013 | Class II | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Cat | December 4, 2012 |
| D-172-2013 | Class II | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Cat | December 4, 2012 |
| D-171-2013 | Class II | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Cat | December 4, 2012 |