FDA recall D-0456-2024

Pyramids Wholesale Inc. · Class I · drug

Product

The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.

Reason for recall

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2024-03-19
Report date
2024-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Los Angeles, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0456-2024