Industry

Drug recall: Red Mammoth capsules recalled due to this reason

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).

February 17, 2022

615

Last Updated on October 15, 2024 by The Health Master

Celebrate Today is voluntarily recalling lot number DK1027, Exp 08/01/2023, of Red Mammoth capsules to the consumer level.

Celebrate Today was informed by Amazon that laboratory analysis has found the product to be tainted with sildenafil and tadalafil, an ingredients known as a phosphodiesterase (PDE-5) inhibitors found in an USFDA approved products for the treatment of male erectile dysfunction.

The presence of sildenafil and tadalafil in Red Mammoth capsules renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Click for more on USFDA

Risk Statement: Consumers with underlying medical conditions who take Red Mammoth 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, Celebrate Today has not received any reports of adverse events related to this recall.

Red Mammoth capsules are marketed as a dietary supplement for male enhancement and is packaged in 10 count blister cards packaged in a carton.

On December 17, 2020, the USFDA 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.

It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Celebrate Today is notifying its customers with this press announcement and sending Amazon messages to its customers and is arranging for the return of all recalled products. Consumers that have Red Mammoth capsules should stop using them.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).

Must read

Drug recall: Red Pill Capsules recalled due to this reason

Drug recall: Blaine Labs recalled of RevitaDerm Wound Care Gel Due to this reason

Drug recall: Mylan Pharma recalled Insulin Glargine inj due to this reason

Drug recall: Sun Pharma, Lupin recall these drugs

Drug recall: Clobetasol Propionate Ointment recalled due to this reason

Drug recall: Torrent recalls 27,000 bottles of BP lowering drug

Also read

0.31% of drug samples tested in 2020-21 declared as spurious or adulterated

USFDA authorised Bebtelovimab as antibody drug

Govt to make registration certificate mandatory for sale of medical devices