March 2022 FDA Recall Drug by Pink Toyz
D-0785-2022 - Marketed Without An Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Pink Toyz on March 29, 2022 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0785-2022

Reason for Recall
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.
Initiated
03-29-2022
Reported
04-27-2022
Quantity
120 blister cards

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89949
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pink Toyz
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA via walmart.com online marketplace
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-31-2024
Product Description About Product Description
Full technical description of the product.
Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.

Batch or Lot Expiration Information

Lot# Lot: 2009066, Exp: 09/2023