# FDA recall D-190-2013

> **Actavis Elizabeth LLC** · Class III · drug recall initiated 2013-02-13.

## Product

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.

## Reason for recall

Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications.  All other test specifications were met.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-190-2013
- **Recalling firm:** Actavis Elizabeth LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-02-13
- **Report date:** 2013-03-13
- **Termination date:** 2014-03-06

- **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-190-2013

## Citation

> AI Analytics. FDA recall D-190-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-190-2013. Source: US FDA. Licensed CC0.

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