FDA MedWatch - Launch Sequence Capsules by Loud Muscle Science

Recall - Due to the Presence of Undeclared Tadalafil

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Launch Sequence Capsules by Loud Muscle Science: Recall - Due to the Presence of Undeclared Tadalafil AUDIENCE: Consumer, Health Professional, Pharmacy ISSUE: Loud Muscle Science is recalling Launch Sequence products because laboratory analysis 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. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The Launch Sequence Capsule products are marketed as dietary supplements for male sexual enhancement.  RECOMMENDATIONS:  Consumers that have the Launch Sequence products should stop using the product and discard. 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. Consumers with questions regarding this recall can contact the company. Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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