Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada
Hauppauge, NY, Loud Muscle Science, LLC is voluntarily recalling the following Launch Sequence products and lots listed in the table below to the consumer level. Laboratory analysis undertaken at the request of Loud Muscle Science, LLC found the products 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 the Launch Sequence products makes these products unapproved drugs for which the safety and efficacy have not been established and therefore, subject to recall.
Risk Statement: The most critical potential adverse health consequence of unintentional consumption of a product tainted with undeclared tadalafil is profound, life-threatening hypotension related to drug-drug interactions with nitroglycerin or guanylate cyclase inhibitors. In the expected-use population, profound hypotension can result in a 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 dietary supplements for male sexual enhancement. The affected products and lots are:
The Launce Sequence capsule products were sold under Amazon ASIN Nos. B07TLPWXDS (USA 60 count) and B08HM7VHCX (Canada 60 count); Launch Sequence Euphoria capsule products were sold under Amazon ASIN Nos. B08ZJX4V9J (Euphoria USA 10 count) and B08ZJX4V9J (Euphoria Canada 10 count); and Launch Sequence Aphrodisia capsule products were sold under Amazon ASIN Nos. 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 USA 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 announcement. Consumers that have the Launch Sequence products should stop using the product and contact the company: 631-270-4188 or e-mail at email@example.com for refund and return information -- Monday through Friday 9AM – 4PM 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
- Regular Mail or Fax: Download form 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.