FDAFDA · Food and drugs·Recall number D-0566-2016
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
Published January 20, 2016 · Recall initiated: November 12, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide
- UPC
- 305550972020
- Lot
- Lot #: 34015516A, Exp 05/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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