The FDA expanded recall to include an additional lot of STEAM, a supplement marketed for erectile dysfunction (ED).
New York product liability attorney alert-Food and Drug Administration (FDA) expands ED dietary supplement product recall with undeclared tadalafil ingredient.
Freeport, NY–Nutracoastal Trading LLC, a Delaware company, has expanded its recall of STEAM, their dietary supplement product. The original recall was announced on July 28th, 2009. The most recent voluntary recall was issued after safety regulators discovered that Lot 90260 contained an undeclared active ingredient, Tadalafil. Tadalafil was omitted from the product label, making STEAM DIETARY SUPPLEMENT an unapproved drug by the U.S. Food and Drug Administration (FDA) www.fda.gov. Tadalafil is found in Viagara, a drug for erectile dysfunction (ED). When taken with nitrates, Tadalafil may cause adverse reactions, such as a drop in blood pressure. Nitrates are often ingested by patients with heart disease, high cholesterol, high blood pressure, or diabetes. Some side effects of the recalled supplement include flushing and headaches. The FDA announced the expansion of the recall to include Lot 90260 on August 21, 2009.
The following item is under federal recall:
– STEAM in white plastic bottles. A bottle contains 5 capsules. The bottle bears the following lot number, expiration date, and UPC code, respectively: 90260, 6 11, and 8 52263 30033 1
The recalled supplement product was sent to retailers across the nation. No illnesses related to the consumption of the product have been reported. The Delaware firm urges consumers to stop taking the supplement. Those who have become ill after taking the supplement should contact their doctor immediately. Illnesses related to the recalled product should be reported online to the FDA’s MedWatch Adverse Event Reporting program. Consumers can also call the FDA, mail the postage-paid FDA form 3500, or fax the form to the FDA. Additional instructions can be found at http://www.fda.gov/Safety/Recalls/ucm179964.htm. Consumers negatively affected by the recalled product may be entitled to compensation for damages.
Staff writer reporting for New York product liability attorney news.