Nutracoastal Trading LLC announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement product sold under the following name: S-DROL.
The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by the FDA for Lot 810481 found that the product contains desoxymethyltestosterone, a steroid, making S-DROL DIETARY SUPPLEMENT an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient 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 product listed below was distributed in black plastic bottles to retail stores nationwide.
S-DROL 1 Bottle – 60 Tablets 01 2012 810481 8 272386 000376
No illnesses have been reported to the company to date in connection with this product.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].
Nutracoastal Trading LLC, a Delaware Limited Liability Company, is committed to providing accurate information about its products because of concerns for the health and safety of consumers. Nutracoastal Trading LLC is working voluntarily with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
Consumers should return any unused products 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.