Fitoterapia USA is recalling 19,000 bottles of Mero Macho Passion Fruit Flavored Vitamin C Liquid Supplement because it is tainted with Tadalafil, the active ingredient in an FDA-approved drug that is used for the treatment of male erectile dysfunction. That makes the product an unapproved drug for which safety and efficacy have not been established.
Anyone who takes dietary supplements could have underlying diseases such as hypertension, diabetes, or high cholesterol. And these patients often take nitrates. Use of nitrates and phosphodiesterase 5-inhibits can lead to “fatal cardiovascular collapse,” according to the recall notice. There have not been any reports of adverse reactions related to this recalled product.
The product is marketed as a dietary supplement and is packaged in 8.5 fluid ounces bottles. The Mero Macho Passion Fruit Flavored Vitamin C Liquid Supplement lots and subsequent expiration dates that are recalled are: LOT: ZD-160-18 EXP: 09-07-2019, LOT: ZD-078-19 EXP: 27-04-2020, LOT: ZD-159-17 EXP: 31-05-2018.
The product is packaged in a white bottle with a high print at the bottom. The plastic label is heat sealed. Each bottle has a bar code. It was sold nationwide through retail store sand via internet sales.
Consumers should not use this product if they have purchased it. Fitoterapia USA is notifying distributors and customers by mail and is arranging for the return of all products. Contact the company to arrange for a return.
If you have experienced an adverse event while taking this product, contact your doctor. In addition, you can report it to the FDA. Use the FDA’s MedWatch Adverse Event Reporting Program online, by regular mail, or by fax.
