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Chocolate, Nuts, Supplements Subject Of Recalls

khts_recallsThree recalls were announced today, all sanctioned by the U.S. Food and Drug Administration, including candies and two nutritional supplements.

 

 

Mixed Nut Chocolates

The South Bend Chocolate Company, South Bend, Indiana, is recalling 174 1-lb bags of Bountiful Blend, a blend of chocolate covered mixed nuts and dried fruits, because it contains undeclared cashews, almonds, pecans, and Brazil nuts. People who have an allergy or severe sensitivity to cashews, pecans, almonds or Brazil nuts run the risk of serious or life-threatening allergic reaction if they consume this product.


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Bountiful Blend was sold via internet sales, mail order and may have been sold nationwide through our distributors to retail stores.

The Bountiful Blend product impacted by the recall is sold under The South Bend Chocolate Company brand name and was produced on or after March 18, 2010. The product under recall is: Bountiful Blend in 1-lb Bags. Products with labels reading Item #154,UPC #644823001549 are subject to this recall.

No illnesses have been reported to date.

This recall was initiated after it was discovered that Bountiful Blend containing cashews, pecans, almonds or Brazil nuts were not listed on the product’s labeling. Subsequent investigation indicates the problem was caused by the printing of ingredient statements and was cut off before the listing of nuts printed.

Consumers who have purchased 1-lb bags of Bountiful Blend are urged to contact The South Bend Chocolate Company at 574-233-2577 Monday through Friday from 8 a.m. to 5 p.m. Eastern time or return them to the place of purchase for a full refund.

 

Solo-Slim Appetite Supressant

EZVille, Ltd. of Ronkonkoma, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Solo Slim® distributed by the company was found to contain an undeclared drug ingredient. Solo Slim® was found to contain Didesmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved Solo Slim®, therefore the safety and effectiveness of the product is unknown.

FDA advises that Solo Slim® 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 Slim® and Solo Slim® Extra Strength products, both marketed as dietary supplements for weight loss. 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.

No illnesses or injuries have been reported to the company to date in connection with these products.

EZVille, Ltd. is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of these affected products. It sincerely regrets any inconvenience to our customers.

Consumers should not consume Solo Slim® and Solo Slim® 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 at 1-866 -673-8483, Monday through Friday, 9:00 am to 5:30 pm, EDT.

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.htm9], by phone 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].

This recall action is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

Undeclared Drug In Diet Supplement

EZVille, Ltd. of Ronkonkoma, NY, has been informed by the US Food and Drug Administration (FDA) that FDA lab analysis of Revivexxx® Extra Strength distributed by the company was found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Revivexxx® Extra Strength an unapproved drug.

FDA advises that this poses a threat to consumers because tadalafil 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.

Revivexxx® Extra Strength is marketed as a dietary supplement sexual enhancer for men. Revivexxx® Extra Strength is packaged in a single dose blister pack containing one oral tablet and bears UPC 8 35470 00207 9. All lots of this product with expiration dates including and prior to August 2013 currently available on the market are being recalled. The product was sold to distributors and retail stores nationwide and via internet sales.

No illnesses or injuries have been reported to the company to date in connection with this product.

EZVille, Ltd. is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of these affected products. It sincerely regrets any inconvenience to our customers.

Consumers should not consume Revivexxx® Extra Strength and should return it 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. Consumers with questions should contact Eric Budzinski at 1-866 -673-8483, Monday through Friday, 9:00 am to 5:30 pm, EDT.

Consumers and health care professionals should report adverse events that may be related to the use of this product to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm9, by phone at 1-800-FDA-1088 or by returning the postage-paid FDA form 3500 which may be downloaded from www.fda.gov/MedWatch/getforms.htm10 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.