Drug product

Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.

D-1336-2022

June 27, 2022

Class I

Product summary

Firm: Loud Muscle Science
Event: Event 90551
Status: Terminated
Classification: Class I
Quantity: 5,421 60-count bottles
Official record key: drug-enforcement:D-1336-2022

Official wording

Reason: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Code information: Lot# 20212001, Exp. Date 12/2024

Distribution pattern: The product was distributed nationwide in the USA and Canada.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.