FDA Recall D-0103-2018
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
RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
Reason for recall
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Recall record
- Recall number
D-0103-2018- 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