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.
Reported: January 20, 2016 Initiated: November 12, 2015 #D-0566-2016
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 9,717 bottles
- Distribution
- Nationwide
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 9,717 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 20, 2016. Severity: Moderate. Recall number: D-0566-2016.
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