D-0106-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 13, 2017
- Initiation Date
- September 15, 2017
- Termination Date
- December 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 198 1-capsule packets
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
All Lots