Drug product
MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88
D-0557-2022
Product summary
- Event
- Event 89543
- Status
- Terminated
- Classification
- Class I
- Quantity
- 750 cartons
- Official record key
drug-enforcement:D-0557-2022
Official wording
Reason: Marketed Without An Approved NDA/ANDA: product was 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 # 2010291, Exp 01/07/2024
Distribution pattern: Product was distributed nationwide in the USA via Amazon Marketplace
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.