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Food Safety News
By Kelsey M. Mackin | August 3, 2017
AMPT Coffee is the third coffee product in the past year to be recalled because laboratory analysis found it contains a prescription drug, which is similar to the active ingredient in Viagra and can be deadly when combined with nitrates frequently found in heart and blood pressure medications.
AMPT Life LLC shipped their coffee product, which contains the drugs Sildenafil and Tadalafil, to consumers across the nation, according to the recall notice posted on the Food and Drug Administration’s website. Two months earlier, the FDA reported that the same drugs were identified in a recall of Caverflo Natural Herbal Coffee.
The AMPT Life recall also comes less than a month after Bestherbs Coffee LLC recalled product because it was found to contain another erectile dysfunction medication, desmethyl carbondenafil.
The trio of coffee recalls comes almost a year after the Food and Drug Administration posted a public notice on Aug. 30, 2016, reporting that it found desmethyl carbodenafil in Kopi Jantan Tradisional Natural Herbs Coffee, which is also marketed as a male enhancement product.
No illnesses had been confirmed in relation to the AMPT Life coffee product as of the posting of the recall on Aug. 1. However, Caverflo’s May recall reported one death in connection with its product.
AMPT Coffee also contains milk, a known allergen, which is not declared on the packaging as required by federal law. People who have milk allergies or sensitivities and consume this product are at risk of serious or life threatening reactions, according to the recall notice.
The undeclared Sildenafil and Tadalafil in the coffee could interact with nitrates in other prescription drugs, such as nitroglycerin. It is common for men with diabetes, high blood pressure, high cholesterol or heart disease to be prescribed medications with nitrates. The undeclared drug in the AMPT coffee could lower blood pressure to dangerous levels.
There is concern consumers may have unused portions of the recalled red packets, which were packaged in red boxes, in their homes. To determine if they have the recalled product, consumers should check the red box and red packets with black writing, for the UPC number 6942630912.
“AMPT Coffee is used as a libido booster,” according to the recall notice, “AMPT Coffee is consumed as an instant coffee. AMPT Coffee was distributed nationwide to consumers via internet at www.amptcoffee.com.”
No illnesses has been reported in connection with the recalled AMPT as of Aug. 1. The company is continuing to notify its customers of the recall by phone. Consumers are being urged to discard the product immediately and contact their doctors.
This recall is the most recent in a series of warnings and recalls involving coffee products posted by FDA in the past year, specifically because of undeclared erectile dysfunction drugs:
• In September 2016 FDA posted a warning about Stiff Bull brand “Herbal Coffee” because it found undeclared desmethyl carbodenafil while inspecting international mail shipments.
• In May this year Caverflo.com recalled its “Natural Herbal Coffee” after FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil, which are the active ingredients in two prescription drugs used for the treatment of erectile dysfunction. Caverflo.com has received a report of an individual death after use of the coffee. Caverflo Natural Herbal Coffee may also contain undeclared milk according to the May recall notice.
• In July this year FDA posted a recall for Bestherbs Coffee LLC brand “New of Kopi Jantan Tradisional Natural Herbs Coffee” because FDA laboratory analysis confirmed the presence of desmethyl carbondenafil.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of such products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.
In its warning notices, the FDA reported “a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.”
“These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being ‘all natural.’ FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients,” according to the FDA’s notices warning against the coffee products.
