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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Nutracoastal Trading LLC conducts voluntary nationwide recall of S-DROL Dietary supplement lot 810481

 

Consumer contact:
David McLoughlin
866-803-2434

FOR IMMEDIATE RELEASE - Freeport, NY - July 28, 2009 - 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. Acute liver injury is known to be a possible harmful effect of using anabolic steroid-containing products. In addition, anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

The recalled product listed below was distributed in black plastic bottles to retail stores nationwide.

Brand Name 
Size
Exp. Date
Lot
UPC
S-DROL1 Bottle - 60 Tablets01 20128104818 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.
 

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