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Recall Observatory FDA recall evidence

Drug product

Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.

D-0785-2022

March 29, 2022

Class I

Product summary

Firm
Pink Toyz
Event
Event 89949
Status
Terminated
Classification
Class I
Quantity
120 blister cards
Official record key
drug-enforcement:D-0785-2022

Official wording

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product 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: 2009066, Exp: 09/2023

Distribution pattern: Nationwide in the USA via walmart.com online marketplace

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.