FDA recall D-0635-2021

Product

maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028

Reason for recall

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2021-05-18

Report date

2021-06-30

Termination date

2023-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0635-2021