FDA recall D-1085-2019

Product

Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-03-14

Report date

2019-04-03

Termination date

2023-02-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orange, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1085-2019