Why it was recalled
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Product description
RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
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-0103-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 15, 2017
- FDA report date
- Dec 13, 2017
- Quantity
- 925 1-capsule packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Gadget Island, Inc
Original FDA data
Every field from FDA enforcement report D-0103-2018, 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-0103-2018
- Classification
- Class I
- Recalling firm
- Gadget Island, Inc
- Product quantity
- 925 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
- RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 15, 2017
- Initial firm notification
- Center classification date
- Dec 4, 2017