# FDA recall D-172-2013

> **Amedra Pharmaceuticals LLC** · Class II · drug recall initiated 2012-12-04.

## Product

Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09

## Reason for recall

Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-172-2013
- **Recalling firm:** Amedra Pharmaceuticals LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-12-04
- **Report date:** 2013-03-06
- **Termination date:** 2014-03-21

- **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-172-2013

## Citation

> AI Analytics. FDA recall D-172-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-172-2013. Source: US FDA. Licensed CC0.

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