Drug product
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
D-1408-2014
Product summary
- Event
- Event 68225
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,882 bottles
- Official record key
drug-enforcement:D-1408-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Code information: Lot # 34013122A, Exp 11/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification