F&S Medical Supply, dba Pink Toyz is voluntarily recalling one lot of Pink Pussycat 3000 mg capsules to the consumer level. FDA analysis has found the product Pink Pussycat to be tainted with sildenafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in an FDA approved product for the treatment of male erectile dysfunction. The presence of sildenafil in Pink Pussycat capsules renders the product an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Risk Statement: Consumers with underlying medical conditions who take Pink Pussycat with undeclared sildenafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, 03/30/2022, Pink Toyz has not received any reports of adverse events related to this recall.
The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 1 count blister pack, UPC [8 91875 00462 6]. The affected Pink Pussycat lot includes the following LOT# 2009066 and expiration date 09/2023 which was sold only by Pink Toyz The product can be identified by Pink Pussycat Sensual Enhancement capsule. Pink Pussycat was distributed nationwide to Walmart marketplaces.
Pink Toyz is notifying its distributors and customers by email and is arranging for return or destroy of all recalled product. Consumers that have Pink Pussycat capsules which is being recalled should discard and ask for a full refund where they placed order.
Consumers with questions regarding this recall can contact Pink Toyz at 747-202-3335 or firstname.lastname@example.org on Monday to Friday starting from 04/01/2022, 9 AM to 5 PM PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Original recall and updates at FDA