Products found to contain undeclared medicines
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| The United States: ABC SALES 1 INC issues voluntary nationwide recall of MAC DADDY RED and MAC DADDY PURPLE capsules due to the presence of undeclared sildenafil and tadalafil |
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The US Food and Drug Administration (FDA) announces that ABC SALES 1 INC is voluntarily recalling MAC DADDY RED Capsules (lot 1230004) and MAC DADDY PURPLE Capsules (lot 1230005) to the consumer level. ABC SALES 1 INC was informed by Amazon that laboratory analysis found MAC DADDY RED Capsules to be tainted with sildenafil and tadalafil and MAC DADDY PURPLE Capsules to be 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 and therefore, subject to recall.
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.
These products are marketed as dietary supplements for male sexual enhancement.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abc-sales-1-inc-issues-voluntary-nationwide-recall-mac-daddy-red-and-mac-daddy-purple-capsules-due
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Feb 9, 2022
Issued at HKT 13:00
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