Recall: Rhino 7, Papa Zen, Fifty Shades, and Grand X Dietary Supplement
On 2017-09-20, the FDA announced that Gadget Island dba Gear Isle is conducting a recall on Dietary Supplement due to possible undeclared sildenafil, tadalafil. The recalled products were sold under the brand name(s) Rhino 7, Papa Zen, Fifty Shades and and Grand X during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 5 drugs recalls due to potential undeclared ingredients, including dietary supplement, man of steel 1 and man of steel 2 and more. Additionally, there have been 19 drug and medical device recalls due to other health hazards as well as 73 food recalls.
Company Contact Information:
Name: Gadget Island dba Gear Isle
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Dietary Supplement
Brand Name(s): Rhino 7, Papa Zen, Fifty Shades, and Grand X
Reason for Recall: Undeclared Active Pharmaceutical Ingredients.
Official Recall Date: 2017-09-20
Additional information provided by the FDA.gov:
Gadget Island, Inc. is voluntarily recalling Rhino 7 Platinum 5000 capsules, LOT# R7-D5K1011H, Papa Zen 3300 capsules, LOT# NSS050888, Fifty Shades 6000 capsules, all Lots, Grande X 5800 capsules, all Lots, to the consumer level. FDA analysis has found the products to be 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 Rhino 7 Platinum 5000, Papa Zen 3300, Fifty Shades 6000, and Grande X 5800, renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.