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This effect can occur without warning at any time while taking this drug. Do not take this drug right before or after heart bypass surgery (CABG).This drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. The risk may be greater in older adults or if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). This effect can happen at any time while taking this drug but is more likely if you take it for a long time. Nonsteroidal anti-inflammatory drugs (including ibuprofen) may rarely increase the risk for a heart attack or stroke.

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Always ask your health care professional for complete information about this product and your specific health needs. This information is not individual medical advice and does not substitute for the advice of your health care professional. This information does not assure that this product is safe, effective, or appropriate for you.

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Food and Drug Administration.IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This recall is being conducted with the knowledge of the U.S.

#Red pill with i 2 download

Regular Mail or Fax: Download form 2 or call 1-80 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-80.

Complete and submit the report Online: 1.

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.Īdverse 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.

Consumers that have The Red Pill which is being recalled should stop using the product.Ĭonsumers with questions regarding this recall can contact Your Favorite Shop by phone number (551)-255-0862 or e-mail Monday thru Friday from. 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. It also encouraged online marketplaces to ensure these products are not sold on their platforms. 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. The product was distributed via the internet and fulfilled by Amazon at nationwide in the USA. The product can be identified by the label below. 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.

To date, Your Favorite Shop has not received any reports of adverse events related to this recall. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

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. 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.Ĭonsumers with underlying medical issues who take The Red Pill with undeclared tadalafil may experience serious health risks. 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. Expiry of The Red Pill, packaged in 10-count blisters packaged in a carton to the consumer level. FOR IMMEDIATE RELEASE – – Jackson, NJ – Your Favorite Shop is voluntarily recalling lot # 26436989.