Company Announcement Date: December 17, 2019
FDA Publish Date: December 17, 2019
Product Type: Drugs
Reason for Announcement: Presence of Undeclared Tadalafil
Company Name: Motto International Corp
Brand Name: No Brand name Listed on Package
Product Description: Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, Panther Platinum 30000
Motto International Corp. is voluntarily recalling all lots of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, to the consumer level. FDA analysis has found Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000 to be tainted with undeclared tadalafil. Tadalafil is an FDA approved drug indicated for the treatment of male sexual enhancement. The presence of tadalafil in these products renders them unapproved drugs for which safety and efficacy has not been established and, therefore, subject to recall.
Consumption of a product with undeclared tadalafil may pose a risk to consumers who take prescription medications containing nitrates (such as nitroglycerin). The combination of tadalafil and nitrates may lower blood pressure to dangerous levels which can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected. To date, Motto International Corp. has not received any reports of adverse events related to this recall.
The Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000 products are marketed as dietary supplements for male sexual enhancement and are packaged in 2, 4, and 10 capsule blister pack cards. The product can be identified by the product labels attached below. Product was sold locally to 2 Dallas convenience stores.
Motto International Corp. is notifying its customers by email and is arranging for replacement of recalled products, at the request of the customer. Consumers who purchased the product in October, 2019 should stop consuming it and return any unused product to Motto International Corp., 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.
Consumers with questions regarding this recall can contact Motto International Corp. via email at firstname.lastname@example.org at any time or by phone at 469-644-4398 on Monday through Friday between the hours of 9 a.m. to 5 p.m. Central Time.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.