FDA recall D-0206-2024

Product

Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ

Reason for recall

Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

Distribution

Nationwide in the USA. Product was sold via Amazon's Marketplace.

Key facts

Status

Ongoing

Initiation date

2023-11-29

Report date

2024-01-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Hampton, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0206-2024