Integrity Products, based in St. Louis, Missouri, is conducting a voluntary recall of a specific lot (HGW221116) of the Ram It & To The Moon capsules due to contamination with sildenafil and Tadalafil. The FDA's investigation has confirmed the presence of these substances, which are approved for treating erectile dysfunction. However, their inclusion in the Ram It & To The Moon products makes them unapproved drugs, lacking established safety and efficacy, hence prompting the recall.
The risk associated with these tainted products primarily affects men with underlying health conditions such as diabetes, high blood pressure, high cholesterol, or heart disease. Combining these capsules with certain medications could potentially lead to a dangerous drop in blood pressure, posing life-threatening consequences.
Integrity Products has not received any reports of adverse events linked to this recall thus far. The affected items are marketed as dietary supplements for enhancing male sexual performance and come in blister card packaging containing 10 capsules per box. The distribution of Ram It & To The Moon capsules was nationwide through online sales, prompting this public announcement to reach all potential consumers as the company lacks specific customer information for direct notification.
Customers who have purchased the Ram It & To The Moon products are advised to discontinue use immediately and properly dispose of the product to ensure safety.
Source: FDA
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Consumers with questions regarding this recall can contact Integrity Products. at integrityproductsusa@gmail.com, St Louis MO Monday – Friday 9am to 9pm Eastern Standard Time 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.
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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.
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