STEAM, S-DROL Dietary Supplements Recalled For Undeclared Drug IngredientsJul 30, 2009 | Parker Waichman LLP
STEAM and S-DROL dietary supplements are being recalled today by Nutracoastal Trading LLC. According to a notice posted on the Food & Drug Administration (FDA) website, the STEAM and S-DROL dietary supplement products are unapproved drugs because they contain pharmaceutical ingredients not listed on the product labels.
Lab analysis by the FDA on the recalled STEAM product found that it contains sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for erectile dysfunction. Approved versions of this drug are sold under various names, including Viagra. The S-DROL product contains desoxymethyltestosterone, a steroid.
The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.
The recalled STEAM product was distributed in white plastic bottles to retail stores nationwide. The recall involves STEAM Dietary Supplements, Lot# 80214, UPC 8 52263 30033 1 in the 1 Bottle - 5 Capsule size.
The recalled S-DROL product was distributed in black plastic bottles to retail stores nationwide. The recall involves S-DROL Dietary Supplements, Lot# 810481, UPC 8 272386 000376, Expiration Date 01 2012, in the 1 Bottle - 60 Tablet size.
Customers who have either of these products in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to the supplements. Consumers should return any unused product to the retail location where they were purchased or contact Nutracoastal Trading LLC directly at 866-803-2434 Monday - Friday, 9 am to 5 pm EDT.
It is becoming apparent that many so-called dietary supplements are, in reality, unapproved drugs that contain pharmaceutical ingredients. Earlier this week, the FDA warned that some body building supplements that claim to contain steroid-like ingredients really contain anabolic steroids. Such products have been associated with serious liver injuries, as well as stroke, kidney failure and pulmonary embolism (artery blockage in the lung).
The FDA also said it had issued a Warning Letter to American Cellular Laboratories regarding its Xtreme supplements. According to the agency, the products named in the letter are purported to contain steroid-like ingredients, but in fact contain synthetic steroids. The FDA has received five adverse event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories including TREN-Xtreme and MASS Xtreme.