FDA recall D-0725-2022

Product

Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.

Reason for recall

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Distribution

Nationwide in the USA via www.walmart.com

Key facts

Status

Terminated

Initiation date

2022-02-09

Report date

2022-03-23

Termination date

2022-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bentonville, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0725-2022