The Recall Desk
CriticalFDA (Drugs)·D-1085-2019·Announced 2019-04-03

Blue Fusion Capsules Recalled for Undeclared Prescription Ingredients

Ata International Inc is recalling Blue Fusion Capsules because FDA analysis found undeclared prescription ingredients, including Sildenafil and Tadalafil.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Ata International Inc is recalling Blue Fusion Capsules, 1-count blister packs, distributed by DNS Distribution. The product is identified by UPC 7 48252 66460 0. The recall covers all lots of the product.

The FDA is recalling this product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined that the product contains undeclared ingredients, specifically Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.

The product was distributed nationwide within the United States. Consumers should stop using the product and contact the distributor or manufacturer for further instructions.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.