Products found to contain undeclared medicines
|
| |
| The United States: Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada |
| |
The US Food and Drug Administration (FDA) announces that Loud Muscle Science, LLC is voluntarily recalling the following Launch Sequence products to the consumer level:
- Launch Sequence Capsules (lot number: C07172101, 2022054, 20212001, 2022104)
- Launch Sequence Euphoria Capsules (lot number: C07172101, 2022054, 20212001, 2022104)
- Launch Sequence Aphrodisia Capsules (lot number: C07172101, 2022054, 20212001, 2022104)
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.
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.
Please refer to the following website in FDA for details:http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/loud-muscle-science-llc-issues-voluntary-recall-launch-sequence-capsules-due-presence-undeclared
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Saturday, July 30, 2022
Issued at HKT 12:00
|
| |
