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Recall Observatory FDA recall evidence

Drug product

Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.

D-0725-2022

February 09, 2022

Class I

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

    reason.no_named_rule · v1.0.0

    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.