Drug product
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
D-0725-2022
Product summary
- Firm
- Walmart Stores
- Event
- Event 89686
- Status
- Terminated
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-0725-2022
Official wording
Reason: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Code information: Lot: DK1027, Exp 08/01/2023
Distribution pattern: Nationwide in the USA via www.walmart.com
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.