- Company Announcement Date:
- FDA Publish Date:
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- Reason for Announcement:
Recall Reason DescriptionUndeclared Tadalafil
- Company Name:
- Brand Name:
- Product Description:
Product DescriptionRise Up Red Edition Capsules
FOR IMMEDIATE RELEASE – 2/10/22 – Wilmington DE, Positive-Health is voluntarily recalling lot number 48658908 with Expiry 9/9/23 of Rise Up Red Edition Capsules packaged in 10-count blisters packaged in a carton to the consumer level. Positive-Health 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 Rise Up Red Edition 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 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.
The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 10-count blisters packaged in a carton. 10 count, Lot 48658908, Exp. 9/9/23, ASIN B08JCWG84D. 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.
Positive-Health is notifying its customers by this press announcement and by Amazon Messaging and is arranging for return of all recalled products. Consumers that have Rise Up Red Edition which is being recalled should stop using the product.
Consumers with questions regarding this recall can contact Positive-Health by phone number: (302)-824-3223 or e-mail at email@example.com Monday through Friday 9AM – 5PM 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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm1
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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