FDA Recall D-1085-2019
Ata International Inc · Orange, CA
Class I — life-threatening Terminated 1446 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1085-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide within the United States
- Recall initiated
- 2019-03-14
- Classified by FDA Center
- 2019-04-09
- FDA published
- 2019-04-03
- Terminated
- 2023-02-27
- Recalling firm
- Ata International Inc
- Firm location
- Orange, CA