Class II
Terminated
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.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- November 12, 2015
- Posted
- January 20, 2016
- Recall Number
- D-0566-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,717 bottles
- Firm Location
- North Wales, PA, United States
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Distribution
Nationwide
Lot / Code Info
Lot #: 34015516A, Exp 05/16
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