Dextroamphetamine Sulfate Extended Release Capsules — Class II drug recall D-173-2013
Terminated recall by Amedra Pharmaceuticals LLC, reported 2013-03-06, distributed nationwide. Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the
| Recall number | D-173-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amedra Pharmaceuticals LLC, Horsham, PA, United States |
| Recall initiated | 2012-12-04 |
| Classified | 2013-02-27 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2014-03-21 |
| Distributed | Nationwide (US) |
| Quantity | 10,968 bottles |
| Reason classes | specification failure |
| NDC | 64720-0329-09 |
| Lot numbers | 220843 |
| Expiration dates | 2013-11-30 |
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 for recall
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-173-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.