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Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug Ingredient
AUDIENCE: Cardiology, Consumer
ISSUE: FDA lab analysis of Solo Slim was found to contain the undeclared drug ingredient Didesmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. This poses a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients, and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
BACKGROUND: Solo Slim is packaged in white plastic bottles with blue screw-on cap containing 30 capsules per bottle and bears UPC 8 35470 00206 9. Solo Slim Extra Strength is packaged in white plastic bottles with blue screw-on cap containing 30 capsules per bottle and bears UPC 8 35470 00220 5. All lots of these products with expiration dates including and prior to August 2013 currently available on the market are being recalled. The products were sold to distributors and retail stores nationwide and via internet sales.
RECOMMENDATION: Consumers should return the product immediately to the place of purchase for a full refund. Consumers should contact their physician if they have experienced any problems that may be related to taking this product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the company Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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