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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.

 

Jen-On Herbal Science International, Inc. Issues A Voluntary Nationwide Recall of H S Joy of Love, a Product Marketed as a Dietary Supplement

 

Contact:
Dr. William Chang
(626) 333-9998

 

FOR IMMEDIATE RELEASE -- City of Industry, CA -- April 17, 2007- Jen-On Herbal Science International, Inc. 205 Russell St., City of Industry, CA 91744, announced today that it is conducting a voluntary nationwide recall of the company's supplement product sold under the name H S Joy of Love. Jen-On Herbal Science International, Inc. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of H S Joy of Love samples found the product contains Piperadino Vardenafil, an analog of Vardenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). Piperadino Vardenafil is close in structure to Vardenafil and is expected to possess a similar pharmacological and adverse event profile. This poses 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.

H S Joy of Love is sold nationwide. The H S Joy of Love product is sold as a 12-capsule blister pack packaged in a retail box.

Consumers who have H S Joy of Love in their possession should stop using it immediately. In the event of any adverse side effects due to its consumption, consumers should contact a physician right away. Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portion be returned to Jen-On Herbal Science International, Inc. for a full purchase price refund by calling (626) 333-9998 for instructions on the return and refund process.

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

Jen-On Herbal Science International, Inc. apologizes for any inconvenience and expresses its concerns for the health of consumers by conducting a voluntary recall action. Jen-On Herbal Science International, Inc. promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.

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