D-1338-2022 Class I Terminated
FDA drug recall D-1338-2022 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: 500 4-count tins.
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
- 500 4-count tins
Product Description
Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
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 # 2022104, exp. date 04/2025