D-0143-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 23, 2019
- Initiation Date
- September 19, 2019
- Termination Date
- April 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,129 100-count bottles
Product Description
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
Reason for Recall
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Distribution Pattern
Nationwide in the US
Code Information
Batch 07319032A1, Exp 02/2021