If you do not follow the instructions concerning our policy on external links
your submission will be sent to the spam folder.
Fitoterapia USA Inc., is voluntarily recalling 19,000 bottles of MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT, liquid dietary supplement to the consumer level. FDA analysis has found the product to be tainted with Tadalafil. Tadalafil is an active ingredient in a FDA- approved prescription drug that is used for the treatment of male erectile dysfunction. The presence of Tadalafil in Mero Macho renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Consumers who take dietary supplements for erectile dysfunction could have underlying diseases such as diabetes, hypertension, or high cholesterol. Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and phosphodiesterase 5- inhibitors can lead to fatal cardiovascular collapse. To date, Fitoterapia USA Inc. has not received any reports of adverse events related to this recall.