FDA recall D-0143-2020

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

Reason for recall

Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2019-09-19

Report date

2019-10-23

Termination date

2023-04-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0143-2020