Drug recall: RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside…
Class I FDA enforcement event 78151. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Gadget Island, Inc started this drug recall on 15 Sep 2017. The firm address in the FDA record is in Newark, CA. FDA put the recall in Class I. FDA event 78151 has 4 product records. The first FDA enforcement report date is 13 Dec 2017. The record gives the status Terminated, with the termination date 4 Dec 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in the USA
Recalling firm
Gadget Island, Inc, Newark, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0103-2018 | RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224 | 925 1-capsule packets | Class I | Terminated | 13 Dec 2017 |
| D-0104-2018 | PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587 | 89 1-capsule packets | Class I | Terminated | 13 Dec 2017 |
| D-0105-2018 | FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056 | 273 1-capsule packets | Class I | Terminated | 13 Dec 2017 |
| D-0106-2018 | 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,… | 198 1-capsule packets | Class I | Terminated | 13 Dec 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2017
- 343
- Share of these events in Class I
- 13%
- Product records in this event
- 4Median of the firm: 4
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 Apr 2023 | Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 981 | Drug | Class I | 3 |
Official channels
- FDA enforcement report D-0103-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 78151. https://recallregister.com/fda/i/78151/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in the USA
- What quantity of product is in FDA event 78151?
- The event has 4 product records. The first record gives this quantity:
925 1-capsule packets
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2017 have the same class?
- 13% of the 343 drug events that started in 2017 are in Class I.