Med Man Distribution expanded its recall for dietary supplements including all lots of “Bow and Arrow libido enhancer for men” for the potential undeclared presence of sildenafil, the U.S. Food and Drug Administration said in a statement. Sildenafil is an FDA-approved prescription drug for erectile dysfunction.
The company had earlier in November 2019 recalled all lots of “Up2 THERE IS NO OTHER All Natural Libido for Men & Women” dietary supplement as it was found to be tainted with sildenafil.
The presence of sildenafil rendered the products unapproved drugs for which safety and efficacy have not been established.
The company is now recalling one lot of UP2 of ten count units, four count units and single count units as well as one lot of Bow and Arrow of ten count units and four count units. The Bow & Arrow libido enhancer and Up2 dietary supplement were distributed in the USA to Regal Labs and to their retailers across the U.S.
The company is yet to receive any reports of adverse events involving the recalled products.
Med Man warned that this undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels which can be life threatening.
People with diabetes, high blood pressure, high cholesterol, or heart disease may be more vulnerable as they often take nitrates, it added.
The company urged consumers stop using the recalled products and and return to retailer for refund.
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