Recalls / Class I
Class ID-0106-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- All Lots
Why it was recalled
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Recalling firm
- Firm
- Gadget Island, Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 5889 Central Ave, N/A, Newark, California 94560-4465
Distribution
- Quantity
- 198 1-capsule packets
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-09-15
- FDA classified
- 2017-12-04
- Posted by FDA
- 2017-12-13
- Terminated
- 2018-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0106-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.