FDA Recall D-0106-2018
Gadget Island, Inc · Newark, CA
Class I — life-threatening Terminated 445 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440
Reason for recall
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Recall record
- Recall number
D-0106-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide in the USA
- Recall initiated
- 2017-09-15
- Classified by FDA Center
- 2017-12-04
- FDA published
- 2017-12-13
- Terminated
- 2018-12-04
- Recalling firm
- Gadget Island, Inc
- Firm location
- Newark, CA