Summary

Company announcement date:
FDA Publication Date:
Type of product:
Medications
Reason for announcement:

Description of the reason for the recall

Undeclared tadalafil

Company Name:
Your favorite store
Brand:
Product Description:

company announcement

FOR IMMEDIATE RELEASE – 2/8/2022 – Jackson, NJ – Your favorite shop is voluntarily recalling Lot # 26436989. Expiring 10/30/2023 of The Red Pill, packaged in blister packs of 10 units packed in a consumer level carton. Your favorite store has been notified by Amazon that lab analysis revealed the product was contaminated with tadalafil, an ingredient in FDA-approved products for the 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 whose safety and effectiveness have not been established and therefore subject to recall.

Consumers with underlying medical conditions who take The Red Pill with undeclared tadalafil may pose serious health risks. For example, PDE-5 inhibitors can interact with nitrates found in some prescription medications (such as nitroglycerin) by lowering blood pressure to dangerous, potentially life-threatening levels. 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 the enhancement of male sexual performance and is packaged in blister packs of 10 units packed 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 shipped by Amazon to www.amazon.com nationwide in the United States.

On December 17, 2020, the FDA issued a press release warning consumers to avoid certain products found on Amazon, eBay, and other retailers due to hidden and potentially harmful drug ingredients. He also encouraged online marketplaces to ensure that these products are not sold on their platforms.

Your favorite store notifies its customers through this press announcement and sends Amazon messages to its customers and arranges for the return of all recalled products. Consumers who have The Red Pill being recalled should stop using the product.

Consumers with questions regarding this recall may contact Your Favorite Shop by phone (551)-255-0862 or email yourfavoriteshoppills@gmail.com Monday through Friday. 9:00 a.m. to 4:00 p.m. EST. Consumers should contact their doctor or health care provider if they have experienced any problems that may be related to taking or using this pharmaceutical 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 United States Food and Drug Administration.

FDA press release


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