Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02
Reported: August 12, 2015 Initiated: June 24, 2015 #D-1283-2015
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 19,504 bottles
- Distribution
- Nationwide
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr Laboratories, Inc. Forest, VA for Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0555-0972-02. Recalled by Teva Pharmaceuticals USA. Units affected: 19,504 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 12, 2015. Severity: Moderate. Recall number: D-1283-2015.
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