D-1336-2022 Class I Terminated

Recalled by Loud Muscle Science — Hauppauge, NY

FDA drug recall D-1336-2022 was initiated by Loud Muscle Science on June 27, 2022 and is designated Class I. Reason for recall: 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 unapprov… The recall status is terminated (terminated February 8, 2023). Affected quantity: 5,421 60-count bottles.

Recall Details

Product Type
Drugs
Report Date
July 27, 2022
Initiation Date
June 27, 2022
Termination Date
February 8, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,421 60-count bottles

Product Description

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

Reason for Recall

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.

Distribution Pattern

The product was distributed nationwide in the USA and Canada.

Code Information

Lot# 20212001, Exp. Date 12/2024