# FDA recall D-385-2014

> **Amedra Pharmaceuticals LLC** · Class II · drug recall initiated 2013-10-07.

## Product

Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09

## Reason for recall

Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-385-2014
- **Recalling firm:** Amedra Pharmaceuticals LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-07
- **Report date:** 2014-01-01
- **Termination date:** 2014-10-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horsham, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-385-2014

## Citation

> AI Analytics. FDA recall D-385-2014. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-385-2014. Source: US FDA. Licensed CC0.

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