Blue Fusion Capsules recalled over undeclared ingredients

Recall date

March 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ata International Inc recalls Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riversi…

Recall number

D-1085-2019

FDA classification

Class I

Brand / firm

Ata International Inc

Sold / distributed

Nationwide within the United States

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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