Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15m Supply Disruption — Amedra Pharmaceuticals LLC (M
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15m Supply Disruption — Amedra Pharmaceuticals LLC (M is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15m; Manufacturer: Amedr
| Drug name | Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15m |
|---|---|
| Manufacturer | Amedra Pharmaceuticals LLC |
| Recall/Disruption reason | Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Leve |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-385-2014 |
| Initiation date | 20131007 |
| Quantity affected | 10,992 bottles |
| Dosage form | Drugs |
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