Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Undeclared Tadalafil
- Company Name:
- Your Favorite Shop
- Brand Name:
- Product Description:
Company Announcement
FOR IMMEDIATE RELEASE – 2/8/2022 – Jackson, NJ – Your Favorite Shop is voluntarily recalling lot # 26436989. Expiry 10/30/2023 of The Red Pill, packaged in 10-count blisters packaged in a carton to the consumer level. Your 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 and therefore, subject to recall.
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.
The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, the affected lot includes lot # 26436989, Expiry 10/30/2023. The product can be identified by the label below. The product was distributed via the internet and fulfilled by Amazon at www.amazon.com nationwide in the USA.
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.
Your Favorite Shop is notifying its customers by this press announcement and sending Amazon messages to its customers and is arranging for return of all recalled products. Consumers that have The Red Pill which is being recalled should stop using the product.
Consumers with questions regarding this recall can contact Your Favorite Shop by phone number (551)-255-0862 or e-mail [email protected] Monday thru Friday from. 9AM to 4PM EST. 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.
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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
