# FDA recall D-0813-2016

> **Actavis Elizabeth LLC** · Class II · drug recall initiated 2016-02-16.

## Product

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for impurities.

## Distribution

US: Nationwide

## Key facts

- **Recall number:** D-0813-2016
- **Recalling firm:** Actavis Elizabeth LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-02-16
- **Report date:** 2016-04-13
- **Termination date:** 2017-09-22

- **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-0813-2016

## Citation

> AI Analytics. FDA recall D-0813-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0813-2016. Source: US FDA. Licensed CC0.

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