Recall Record

Aventura, FL, United States

Zero Xtreme USA recalls

1 recall recorded since 2018, most recently on 15 October 2018. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0

Terminated Class II Drugs

Recall started
15 October 2018
Terminated
18 January 2022
Reason
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
Distribution
Nationwide within the USA.
Initiated
Voluntary: Firm initiated
Recall number
D-0246-2019

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.