Marmex Group is voluntarily recalling all lots of Blue Pearl All Natural Male Enhancement Supplement because the product contains sildenafil, which makes it an unapproved drug. Products with undeclared sildenafil may pose a threat to consumers because the active ingredient can interact with nitrates in some prescription drugs and lower blood pressure to dangerous levels. No adverse effects have been reported to date in connection with this issue.
Consumers with high blood pressure, diabetes, high cholesterol, or heart diseases often take nitrates and may be the most likely to be affected by this undeclared drug. The safety and efficacy of this product has not been established.
The recalled products is Blue Pearl All Natural Male Enhancement Supplement capsules in 500 mg packages. They were marketed as a dietary supplement. The product is packaged in 1 unit of blister packs with UPC number 847046009785. All lot numbers are recalled, with an expiration date of 7/1/2018. The product was distributed nationwide between July 2016 and November 2017 at retail outlets and over the internet.
If you purchased this product, do not use it. Discard of the product according to regulations in your community for drug disposal, or take it back to the store where you bought it for a full refund.
If you think you may have experienced an adverse effect while taking this product, you should see your doctor. You can report problems to the FDA with the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax. Fill out the form at www.fda.gov/medwatch/report.htm.
