FDA MedWatch - MAC DADDY RED and MAC DADDY PURPLE Capsules by ABC SALES 1:

U.S. Food and Drug Administration sent this bulletin at 02/08/2022 06:14 PM EST

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: MAC DADDY RED and MAC DADDY PURPLE Capsules by ABC SALES 1: Recall - Due to the Presence of Undeclared Sildenafil and Tadalafil

AUDIENCE: Consumers, Health Professional, Pharmacy

ISSUE: ABC SALES 1 is recalling two products due to the presence of undeclared ingredients.

MAC DADDY RED capsules, Lot 1230004, were tainted with sildenafil and tadalafil.
MAC DADDY PURPLE capsules, Lot 1230005 were tainted with tadalafil.

Sildenafil and tadalafil are ingredients in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of sildenafil and/or tadalafil in MAC DADDY capsules makes these products unapproved drugs for which the safety and efficacy have not been established.

Consumers with underlying medical issues who take MAC DADDY capsules, with undeclared sildenafil and tadalafil 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, ABC SALES 1 INC 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: These products are marketed as dietary supplements for male sexual enhancement.

RECOMMENDATIONS: On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients.

Consumers that have MAC DADDY RED or PURPLE capsules which are being recalled should stop using.
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.
ABC SALES 1 is arranging for return of all recalled products.

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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