Hi-Tech Pharmaceuticals, Inc. Issues Nationwide Recall of All Lots of Stamina-Rx Dietary Supplement Products

Hi-Tech Pharmaceuticals, Inc. (“Hi-Tech”), 6015-B Unity Dr., Norcross, GA 30071, announced today that it is conducting a nationwide voluntary recall of the company's product sold under the name Stamina-Rx.

On May 1, 2009, Hi-Tech was notified by the Food and Drug Administration (FDA) that FDA's lab analysis of one lot of Stamina-Rx samples found that the product contained the undeclared ingredient − benzamidenafil − a Phosphodiesterase Type 5 (PDE5) inhibitor. The lot number found to contain benzamidenafil is Lot 08141578, Exp. 9/10. Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED). Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil 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 and may be most susceptible to adverse effects from this product.

Stamina-Rx is sold predominantly in health food and drug stores nationwide. The product is sold in 10, 30, and 40-tablet bottles and in 2 and 6-tablet blister packs.

In addition to the one lot described above, Hi-Tech is recalling all other lots of Stamina-Rx because it is an unapproved new drug and misbranded new drug in violation of the Federal Food, Drug and Cosmetic Act (the Act). FDA notified Hi-Tech that, based on certain labeling claims made by the firm, Stamina-Rx is a drug as defined in the Act. Stamina-Rx is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. The labeling at issue was not on bottles of Stamina-Rx, but was contained in certain web-based and print media.

Hi-Tech has been under a Consent Decree of Permanent Injunction with FDA since September 23, 2003. In accordance with the Decree, FDA determined that additional corrective actions were necessary for Hi-Tech to achieve compliance with the Act and the Decree and therefore, on May 1, 2009 FDA ordered Hi-Tech to recall all lots of Stamina-Rx to the consumer level.

Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA’s MedWatch Adverse Event Reporting program online at [www.fda.gov/MedWatch/report.htm] or by phone [1-800-FDA-1088] or by returning the postage paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20853-9787 or fax [1-800-FDA-0178].

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Bodee LLC, Issues A Voluntary Nationwide Recall of Zencore Plus, a Product Marketed as a Dietary Supplement

Bodee LLC, 2222 Avenue of the Stars, 702E, Century City, CA 90067, announced today that it is conducting a nationwide voluntary recall of all the company's supplement product sold under the name Zencore Plus.

Bodee LLC is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Zencore Plus samples found the product contains benzamidenafil which is a newly discovered PDE5 inhibitor. Although different in structure, benzamidenafil is likely to have the same pharmacological properties as the other three PDE5 inhibitors, sildenafil, tadalafil and vardenafil, which are the active ingredients of three FDA approved drugs for Erectile Dysfunction (ED). Zencore Plus does not contain any of these three active ingredients. The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure due to potential interaction between benzamidenafil and organic nitrates. The probability of this occurrence is unknown; therefore, it may cause a public health risk when used as a dietary supplement.

Zencore Plus is sold in health food stores and by mail order on internet nationwide. The Zencore Plus product is sold as a 2-capsule blister pack packaged in a retail booklet with five booklets in a box or as a 10-capsule blister pack in a retail box. The capsules were supplied by Hi-Tech Pharmaceuticals, Inc., Norcross, GA.

Customers who have this product in their possession should stop using it immediately. 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.

Consumers with questions may contact Bodee LLC Monday through Friday 8:00 am to 5:00 pm at (800) 935-0296 or help@zencoreplus.com. Bodee LLC is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to prevent recurrence of these issues. It is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.

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