Regular Mail or Fax: Download form or call 1-80 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-80.Complete and submit the report Online:.Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.Īdverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event fax. The products were distributed Nationwide via internet sales.Ĭonsumers with questions regarding this recall can contact Gear Isle customer service by calling 88 or email at i on Monday to Friday from 10am to 4pm PST. The products can also be identified by using the attached images. The products are marketed as dietary supplements for male sexual enhancement and are packaged as indicated in the table below. dba Gear Isle has not received any reports of adverse events related to this recall. These products are considered tainted and FDA has received adverse event reports from consumers who have purchased these products. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. Risk Statement: Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. 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. 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. is voluntarily recalling Rhino 7 Platinum 5000 capsules, All LOTS, Papa Zen 3300 capsules, LOT# NSS050888, Fifty Shades 6000 capsules, all Lots, Grande X 5800 capsules, all Lots, to the consumer level. Given the lack of FDA oversight of many other supplements similar to this one, patients must be wary that the ingredients listed may not be comprehensive and that serious side effects can occur.Newark, CA, Gadget Island, Inc. Interestingly, since our initial contact with the FDA Safety Reporting Portal, multiple investigations of Rhino products have demonstrated that sildenafil is a non-labeled ingredient. We are unaware of any studies regarding Rhino 7 Platinum 3000.
There are few studies performed and few case reports regarding the roles of various supplements in causing priapism. On initial 2-week follow-up, he had significant fibrosis of the corporal bodies bilaterally and had been unable to achieve an erection. He required bilateral corpo-glanular shunting to alleviate his priapism. A 25-year-old man presented with a 48-h priapism after taking Rhino 7 Platinum 3000. Longstanding priapism is a significant potential side effect. Male enhancement and erectile dysfunction supplements are typically non-Food and Drug Administration (FDA) approved and readily available for purchase by anyone.
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