FDA MedWatch - RISE UP RED EDITION Capsules by Positive-Health:

U.S. Food and Drug Administration sent this bulletin at 02/11/2022 08:25 AM EST

If your email program has trouble displaying this email, view as a webpage.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: RISE UP RED EDITION Capsules by Positive-Health: Recall - Due to the Presence of Undeclared Tadalafil

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: Positive-Health is voluntarily recalling lot number 48658908 of Rise Up Red Edition Capsules because Positive-Health was notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil. Tadalafil is 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 Rise Up Red Edition makes this product an unapproved drug for which the safety and efficacy has not been established.

Consumers with underlying medical issues who take Rise Up Red Edition 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, Positive-Health 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: Rise Up Red Edition Capsules 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 should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Consumers that have Rise Up Red Edition which is being recalled should stop using the product.
Positive-Health 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.

Manage Subscriptions | Unsubscribe All | Help