Drug product
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
D-1283-2015
Product summary
- Event
- Event 71594
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,504 bottles
- Official record key
drug-enforcement:D-1283-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification for unknown impurity
Code information: Lot #: 34015862A, Exp. Date 6/2016 Lot #: 34016376A, Exp. Date 7/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification