Caverflo Natural Herbal Coffee: Recall - Presence of Undeclared Active Pharmaceutical Ingredients

[Posted 05/26/2017]

AUDIENCE: Family Practice, Consumer

ISSUE: Caverflo.com is voluntarily recalling all lots of Caverflo Natural Herbal Coffee, 25 grams to the consumer level. 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). Caverflo.com has received a report of an individual death after use of the coffee. Caverflo Natural Herbal Coffee may also contain undeclared milk.

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. People who have an allergy or severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume this product.

BACKGROUND: Caverflo Natural Herbal Coffee is used as a male enhancement and is packaged in 25 gram black foil packs, UPC 9555671709994. Caverflo.com distributed this product from August 2016 through February 2017. Caverflo Natural Herbal Coffee is consumed as an instant coffee. Caverflo Natural Herbal Coffee was distributed nationwide to consumers via internet at Caverflo.com.

RECOMMENDATIONS: Consumers with questions regarding this recall can contact Caverflo.com at coffeekingb@yahoo.com. 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. 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.

Healthcare professionals and patients 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: www.fda.gov/MedWatch/report
• Download form 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.

[05/25/2017 - Firm Press Release - Careflo]