The products contain ingredients that render them unapproved drugs
Clik here to view.
of ConsumerAffairsImage may be NSFW.
Clik here to view.
Gear Isle is recalling Rhino 7 Platinum 5000, Papa Zen 3300, Fifty Shades and Grande X 5800 capsules.
The products are tainted with sildenafil and tadalafil, which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED), as well as desmethyl carbodenafil which is structurally similar to sildenafil.
The presence of sildenafil, tadalafil and or desmethyl carbodenafil in the recalled products renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
The company says it has not received any reports of adverse events related to this recall.
The following products, marketed as dietary supplements for male sexual enhancement, are being recalled:
| Product | Package size | UPC | Lot # and EXP. date |
|---|---|---|---|
| Rhino 7 Platinum 5000 | 1 capsule in blister pack | 6 17135 86122 4 | All Lots |
| Papa Zen 3300 | 1 capsule in blister pack | 7 18122 03258 7 | NSS050888 EXP: May 2018 |
| Fifty Shades 6000 | 1 capsule in blister pack | 4 026666 146056 | All Lots |
| Grande X 5800 | 1 capsule in blister pack | 6 40793 55544 0 | All Lots |
The recalled products were sold nationwide via the internet.
What to do
Customers who purchased the recalled products can contact Gear Isle customer service at 888-387-4753 Monday Friday from 10am 4pm (PST), or by email at info@gearisle.com
