FDA recall D-0457-2024

Pyramids Wholesale Inc. · Class I · drug

Product

ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L

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-0457-2024