FDA recall D-0625-2018

Product

Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021

Reason for recall

Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.

Distribution

Product was distributed online via eBay.

Key facts

Status

Terminated

Initiation date

2018-03-08

Report date

2018-04-04

Termination date

2019-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Los Angeles, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0625-2018