Pharmagenx, Inc.
340 Rancheros Drive, Suite 166
San Marcos, CA 92069
888 633-7468
URGENT: VENTILEAN RECALL
April 1, 2005
Re: Customers of Pharmagenx Ventilean Products
This is to inform you of a product recall involving: PHARMAGENX VENTILEAN, Dietary Supplement. The product is distributed as a liquid, in 4 and 8 ounce size bottles with a dosage syringe attached, and as soft gel capsules, in 48 and 96 count bottles. The label on the bottles lists the company name Pharmagenx, Las Vegas. In addition, 10 ml single serving plastic ampoules were given as samples and are labeled VENTILEAN 10ml. All lot codes are covered in this recall.
This recall has been initiated due to recent tests that show some lots of the VENTILEAN products contain Clenbuterol. Clenbuterol is an asthma medication that is used overseas, but has not been approved for human use by the U. S. Food and Drug Administration.
At this time Pharmagenx is aware of no serious adverse events resulting from consumers ingesting this product. We are voluntarily recalling all lots of VENTILEAN from the market as a precautionary measure.
Please examine your stocks immediately to determine if you have any VENTILEAN product on hand. If so, discontinue sale of the Ventilean products and promptly return them to our San Marcos facility; ATTENTION: VENTILEAN RECALL for a refund.
If you have distributed any of these products, please immediately contact your accounts, advise them of the recall situation, and have them return their outstanding recalled stocks to you. Return these stocks to Pharmagenx as indicated above. You may forward a copy of this letter if you wish however you must add specific directions to return the product to you. The FDA will be monitoring the recall so your efforts should be carefully documented. This would include having your accounts complete the information on the return FAX regarding the amounts on hand that you are returning. Maintain this tracking for any subsequent returns and to allow an audit of the recall effectiveness.
Please acknowledge your receipt of this recall letter by completing the section below, and faxing (1-760-471-7126) or mailing a copy of this letter to Pharmagenx’s San Marcos headquarters, Attention: Ventilean Recall.
Customers with questions may contact Pharmagenx at 1-888-633-7468.
This recall is being made with the knowledge of the Food and Drug Administration.
Brian Rubach
President
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