Drug product
Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01
D-0143-2020
Product summary
- Event
- Event 83848
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,129 100-count bottles
- Official record key
drug-enforcement:D-0143-2020
Official wording
Reason: Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Code information: Batch 07319032A1, Exp 02/2021
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
Superpotent