Recall Record

Glendale, CA, United States

DASH XCLUSIVE recalls

1 recall recorded since 2018, most recently on 11 May 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Drugs

Recall started
11 May 2021
Reason
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall number
D-0628-2021

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.