FDA recall D-0352-2021

S & B Story LLC · Class II · drug

Product

Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5

Reason for recall

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2021-03-25
Report date
2021-05-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ridgefield Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0352-2021