Company Announcement Date: November 13, 2019
FDA Publish Date: November 13, 2019
Product Type: Dietary Supplements
Reason for Announcement: Due to unapproved active ingredient (sildenafil)
Company Name: Nature’s Rx
Brand Name: Silver Bullet
Product Description: Male Enhancement Capsules
Nature’s Rx is voluntarily recalling Silver Bullet (10 Male Enhancement Capsules, Lot 012541ZX1, Exp 11/2022, UPC: 610877392698. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor. The undeclared PDE-5 inhibitor in the product may pose serious health risks to consumers with underlying medical issues. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
To date, Nature’s Rx has not received any reports of adverse events related to this recall.
The product, Silver Bullet (10 Male Enhancement Capsules), is used as a male enhancement nutritional supplement contained in blister foil sheets and packaged in small boxes containing 10 capsules with an expiry date: 11/2022 and lot number: 012541ZX1, Exp 11/2022, UPC: 610877392698. Silver Bullet (10 Male Enhancement Capsules) was sold on an online website: www.naturalrx.net
Nature’s Rx is notifying its customers by replacement or refund and is arranging for return or replacement of all recalled products. Consumers that have Silver Bullet (10 Male Enhancement Capsules), which is being recalled should stop using and return ship or discard the product.
Consumers with questions regarding this recall can contact Nature’s Rx by phone number or e-mail address 5 days of the week from 10 AM to 6 PM PST., email us at: email@example.com or mail us at: 310 N Indian Hill Blvd Ste 600, Claremont, CA 91711.
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.