Prolatis’ Issues a Voluntary Nationwide Recall of its product Prolatis’ Marketed as Dietary Supplement prior to August 9, 2010

Prolatis’ – Salt Lake City, UT announced today that it is conducting a voluntary nationwide recall of the company’s product sold under the name Prolatis’. Prolatis’ is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analysis has found Prolatis’ to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making Prolatis’ an unapproved drug. The active drug ingredient is not listed on the product label. Product manufactured prior to August 9, 2010 is included in this recall. Prolatis’ is sold nationwide in double blister packs and 40 count bottles.

This recall is being conducted as a precautionary measure. No illnesses or adverse effects have been reported to the company to date in connection with this product.

The undeclared ingredient may pose a threat to consumers because the analogue 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Prolatis’ advises any customer in possession of Prolatis’ to return the product for a full credit towards the new product. Customers can call 1.877.286.5056 for instructions on the return and credit process.

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.htm9], 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 [1-800-FDA-0178].

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J & H Besta Corp. Issues a Voluntary Nationwide Recall of Joyful Slim Herb Supplement Found to Contain an Undeclared Drug Ingredient

J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Joyful Slim Herb Supplement distributed by the company was found to contain undeclared Desmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved this product, therefore the safety and effectiveness of the product is unknown.

FDA advises that this product 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.

Joyful Slim Herb Supplement is marketed as a Natural Herb for Weight Loss. Joyful Slim Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 97966 00200 7. The affected lot/code being recalled is 101408. 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.

J & H Besta Corp. is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of Joyful Slim. It sincerely regrets any inconvenience to our customers.

Consumers should not consume the Joyful Slim Herb Supplement and should return it immediately to the place of purchase for a full refund. Consumers with questions should contact Jason Wang at 877-547-5468, Monday through Friday, 10:00 am to 5:30 pm, EDT.

Any adverse reactions experienced with the use of this product may be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], 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 is being conducted with the knowledge of the U.S. Food and Drug Administration.

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GMP Herbal Products, Inc. Issues a Voluntary Nationwide Recall of a Weight Loss Supplement Found to Contain Undeclared Drug Ingredients

GMP Herbal Products, Inc. has been informed by the Food and Drug Administration (FDA) that Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm contains undeclared drug ingredients. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA has not approved the Pai You Guo products as drug; therefore the safety and effectiveness of this product is unknown. All lots of the following Pai You Guo product are being recalled. The product is sold either in a box of 30 capsules or a bag of 10 g powder.

The products listed above were sold and distributed nationwide via the internet.

FDA advises that these products pose 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.

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

GMP Herbal Products, Inc. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. GMP Herbal Products, Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

Consumers are advised to destroy the above products or return them to the company’s address in Westminster, CA. Consumers with questions may contact GMP Herbal Products, Inc Tuesday through Saturday 11:00 am to 7:00 pm at 1-866-995-8585.

Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/Safety/MedWatch/default.htm.

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