Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chat
Summary
The FDA issued a Class I for Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufac by Pink Toyz. Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products f.
Details
Source
Drug Recall
External ID
D-0785-2022
Action Date
2022-04-27
Status
Terminated
Category
drug
Product Description
Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.
Lot/Code Info: Lot: 2009066, Exp: 09/2023
Quantity Affected: 120 blister cards
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.
Distribution
Nationwide in the USA via walmart.com online marketplace
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-29
Company
Chatsworth, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 31 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pink Toyz) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pink Toyz have FDA actions?
This is the only FDA action we have on record for Pink Toyz in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0785-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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