# FDA recall D-0050-2015

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2014-10-08.

## Product

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA  18960, NDC: 0555-0972-02.   0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016.

## Reason for recall

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

## Distribution

U.S. Nationwide including Puerto Rico.

## Key facts

- **Recall number:** D-0050-2015
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-10-08
- **Report date:** 2014-11-05
- **Termination date:** 2015-09-21

- **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-0050-2015

## Citation

> AI Analytics. FDA recall D-0050-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0050-2015. Source: US FDA. Licensed CC0.

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