FDA MedWatch - Red Pill Capsules by Your Favorite Shop:

Recall - Due to the Presence of Undeclared Tadalafil

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Red Pill Capsules by Your Favorite Shop: Recall - Due to the Presence of Undeclared Tadalafil AUDIENCE: Consumer, Health Professional, Pharmacy ISSUE: Your Favorite Shop is recalling lot # 26436989 of The Red Pill because Favorite Shop was notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in The Red Pill makes this product an unapproved drug for which the safety and efficacy has not been established. Consumers with underlying medical issues who take The Red Pill with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Your Favorite Shop has not received any reports of adverse events related to this recall. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The product is marketed as a dietary supplement for male sexual enhancement. RECOMMENDATIONS: On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Consumers that have The Red Pill which is being recalled should stop using the product. 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. Your Favorite Shop is arranging for return of all recalled products. Consumers with questions regarding this recall can contact the company. Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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