FDA MedWatch - Pink Pussycat Capsules by F&S Medical Supply:

U.S. Food and Drug Administration sent this bulletin at 04/04/2022 12:22 PM EDT

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Pink Pussycat Capsules by F&S Medical Supply: Recall - Due to the Presence of Undeclared Sildenafil

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: F&S Medical Supply, dba Pink Toyz is recalling one lot of Pink Pussycat 3000 mg capsules because 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, Pink Toyz has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The product is marketed as a dietary supplement for male sexual enhancement.

RECOMMENDATIONS:

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.
Consumers that have Pink Pussycat capsules which is being recalled should discard and ask for full refund where they placed order.
Consumers with questions regarding this recall can contact the company.

Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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