Loud Muscle Science, LLC Issues a Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in the United States and Canada

Summary

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Company message

FOR IMMEDIATE RELEASE – 6/27/22 – Hauppauge, NY, Loud Muscle Science, LLC is voluntarily recalling the following Launch Sequence products and batches listed in the table below at the consumer level. Laboratory analysis performed at the request of Loud Muscle Science, LLC found that the products were contaminated with tadalafil, an ingredient in FDA-approved male erectile dysfunction treatment products in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in Launch Sequence products makes these products unapproved drugs for which safety and efficacy have not been established and are therefore subject to recall.

Risk Statement: The most critical potential adverse health consequence of inadvertent consumption of product contaminated with undeclared tadalafil is profound, life-threatening hypotension associated with drug interactions with nitroglycerin or guanylate cyclase inhibitors. In the intended use population, profound hypotension may lead to heart attack, stroke, or death. To date, Loud Muscle Science has not received any reports of adverse events related to this recall.

These tainted Launch Sequence Capsule products are marketed as nutritional supplements for male sexual enhancement. Affected products and batches are:

Launce Sequence capsule products are sold under Amazon ASIN numbers B07TLPWXDS (US 60 count) and B08HM7VHCX (Canada 60 count); Launch Sequence Euphoria capsule products are sold under Amazon ASIN numbers B08ZJX4V9J (Euphoria USA 10 count) and B08ZJX4V9J (Euphoria Canada 10 count); and Launch Sequence Aphrodisia capsules are sold under Amazon ASIN numbers B07QB3S2LV (Aphrodisia USA 4 count) and B09S12VK3F (Aphrodisia Canada 4 count). The products can be identified by the labels and packaging below. The product was marketed via the Internet and fulfilled by Amazon at www.amazon.com Nationwide in the US and www.amazon.ca in Canada, on eBay.com and in retail stores.

Loud Muscle Science is notifying its distributors and customers by letter and this press release and is providing refunds to its customers. Users who have the Launch Sequence products should stop using the product and dispose of it.

Consumers with questions about this recall may contact Loud Muscle Science, LLC at phone number: 631-270-4188 or email at [email protected] — Monday through Friday 9am – 4am EST. Users should contact their physician or health care provider if they have experienced problems that may be related to the intake or use of this medicinal product.

Adverse reactions or quality problems that occur with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program online, by regular mail, or by fax.

This recall is being made with the knowledge of the US Food and Drug Administration.

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