# FDA recall D-1085-2019

> **Ata International Inc** · Class I · drug recall initiated 2019-03-14.

## 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

- **Recall number:** D-1085-2019
- **Recalling firm:** Ata International Inc
- **Classification:** Class I
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-1085-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1085-2019. Source: US FDA. Licensed CC0.

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