# FDA recall D-0395-2015

> **Actavis Elizabeth LLC** · Class II · drug recall initiated 2015-02-10.

## Product

Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only,  Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0395-2015
- **Recalling firm:** Actavis Elizabeth LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-02-10
- **Report date:** 2015-03-11
- **Termination date:** 2015-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elizabeth, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0395-2015

## Citation

> AI Analytics. FDA recall D-0395-2015. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0395-2015. Source: US FDA. Licensed CC0.

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