FDA Drug recall D-173-2013
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma,…
- FDA Drug
- Class II
- terminated
- Published 2013-03-06
On 2013-03-06 the FDA classified a Class II recall of Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma,… by Amedra Pharmaceuticals, citing failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-173-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-04 |
| Published | 2013-03-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Amedra Pharmaceuticals |
| Distribution | US |
Product
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
Reason
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Identifiers
| code_info | Lot 220843, exp 11/30/2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-173-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.