United States
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 are:
- Launch Sequence Capsules. Package Size: 60. (Bottle) ASIN: B07TLPWXDS. UPC Code: 641378938375.
- Launch Sequence Euphoria Capsules. Package Size: 10. (Tin) ASIN: B08ZJX4V9J. UPC Code: 661020846864.
- Launch Sequence Aphrodisia Capsules. Package Size: 4. (Tin) ASIN: B07QB3S2LV. UPC Code: 661020846957.
- Launch Sequence Capsules. Package Size: 60. (Bottle) ASIN: B08HM7VHCX. UPC Code: 661020848166.
- Launch Sequence Euphoria Capsules. Package Size: 10. (Tin) ASIN: B08ZJX4V9J. UPC Code: 661020846864.
- Launch Sequence Aphrodisia Capsules. Package Size: 4. (Tin) ASIN: B09S12VK3F. UPC Code: 661020846957.
The full list of lots and expiry dates is available at the link below. 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 and providing a refund to its customers. Consumers that have the Launch Sequence products should stop using the product and discard.
Consumers with questions regarding this recall can contact Loud Muscle Science, LLC by phone number: 631-270-4188 -- 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.
Company name: Loud Muscle Science, LLC
Brand name: Launch Sequence
Product recalled: Launch Sequence Aphrodisia and Euphoria Capsules
Reason of the recall: Contain Tadalafil
FDA Recall date: June 30, 2022
Source:
www.fda.gov
