Why it was recalled
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
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
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0106-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 15, 2017
- FDA report date
- Dec 13, 2017
- Quantity
- 198 1-capsule packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Gadget Island, Inc
Original FDA data
Every field from FDA enforcement report D-0106-2018, exactly as published.
Show all FDA fields
- City
- Newark
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 78151
- Address
- 5889 Central Ave
- Code information
- All Lots
- Postal code
- 94560-4465
- Report date
- Dec 13, 2017
- Product type
- Drugs
- Recall number
- D-0106-2018
- Classification
- Class I
- Recalling firm
- Gadget Island, Inc
- Product quantity
- 198 1-capsule packets
- Termination date
- Dec 4, 2018
- Reason for recall
- Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 15, 2017
- Initial firm notification
- Center classification date
- Dec 4, 2017