FDA Recall D-1338-2022
Loud Muscle Science · Hauppauge, NY
Class I — life-threatening Terminated 226 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-1338-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- The product was distributed nationwide in the USA and Canada.
- Recall initiated
- 2022-06-27
- Classified by FDA Center
- 2022-08-15
- FDA published
- 2022-07-27
- Terminated
- 2023-02-08
- Recalling firm
- Loud Muscle Science
- Firm location
- Hauppauge, NY