Fitoterapia, a Miami.-based drugmaker, is recalling 19,000 bottles of its dietary supplement for sexual enhancement due to the presence of an active ingredient Tadalafil.
While Tadalafil is FDA-approved, the presence of Tadalafil makes the supplement a drug that has not been approved and tested for safety and efficacy.
The affected product is the Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement.
The recall notice warns that a fatal cardiovascular collapse could occur in consumers who take nitrates and the supplement when they have another condition such as diabetes, hypertension or heart disease.
To date, Fitoterapia has not received any reports of adverse events related to the recall.
The supplement has been distributed nationwide to retail stores and purchased through the internet since April 2019.
Fitoterapia is warning customers with the supplement to stop using it and contact their physician if they have any symptoms that may be related to the supplement.
Read the full report here.
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