An instant coffee marketed as a “natural herbal” aphrodisiac is under recall nationwide after the report of one death and a finding by the FDA that it contains prescription drugs for treatment of erectile dysfunction.
Caverflo.com posted the recall of 25-gram packets of “Caverflo Natural Herbal Coffee” Thursday with the Food and Drug Administration.
“FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED),” according to the recall notice.
“Caverflo.com has received a report of an individual death after use of the coffee. Caverflo Natural Herbal Coffee may also contain undeclared milk.”
The product is a combination of instant coffee and natural aphrodisiacs, according to the Caverflo website, but the recall notice warned the product can interact with prescription medications. Also, people who have an allergy or severe sensitivity to milk could have an allergic reaction if they consume the instant coffee.
“These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates,” according to the recall notice.
The company distributed the instant coffee direct to consumers nationwide via internet sales from August 2016 through February this year. Caverflo is notifying customers of the recall by email.
“Consumers that have Caverflo Natural Herbal Coffee which is being recalled should stop using (it), discard (it) and contact their doctor,” according to the recall notice.
Consumers can identify the recalled “Caverflo Natural Herbal Coffee,” which is packaged in 25-gram black foil packs, by looking for the UPC number 9555671709994 on the package. Consumers with questions regarding this recall can contact Caverflo.com at 214-803-4652.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
- Online: www.fda.gov/medwatch/report.htm Complete and submit the report; or
- Regular mail or fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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