EZVille, Ltd. of Ronkonkoma, New York, just issued a voluntary and nationwide recall of its <"https://www.yourlawyer.com/practice_areas/defective_drugs">Solo SlimÂ®, the U.S. Food and Drug Administration (FDA) just announced. Solo SlimÂ® was found to contain an undeclared drug ingredient.
EZVille, Ltd. was informed by the FDA that its lab analysis of Solo SlimÂ® was found to contain an undeclared drug ingredient, Didesmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved Solo SlimÂ®, therefore the safety and efficacy of the product is unknown.
FDA advises that Solo SlimÂ® 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.
EZVille, Ltd. has decided to recall Solo SlimÂ® and Solo SlimÂ® Extra Strength products, which were both marketed as dietary supplements for weight loss. Solo SlimÂ® is packaged in white plastic bottles with blue screw-on cap containing 30 capsules per bottle and bears UPC 8 35470 00206 9. Solo SlimÂ® 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.
To date, no illnesses or injuries have been reported to the company in connection with these products.
EZVille, Ltd. has discontinued distribution of these affected products. The CPSC is advising consumers not to consume Solo SlimÂ® and Solo SlimÂ® Extra Strength, and should return them 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 these products. Consumers with questions should contact Eric Budzinski of EZVille, toll-free, at 1-866-673-8483, Monday through Friday, 9:00 am to 5:30 pm, Eastern Daylight Time.
Any adverse reactions experienced with the use of these products may be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm]; by telephone 1-800-332-1088 [1-800-FDA-1088]; or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch “Download Forms” page], by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].