Intelli Health Products voluntarily recalls all lots of Duro Extend Capsules for Men marketed as dietary supplements

• Date: December 09, 2010
• Source: Admin

Intelli Health Products has announced the inclusion of all lot codes in its voluntary nationwide recall of Duro Extend Capsules for Men.

This Class I recall follows an FDA report which traced Sulfoaidenafil, an analogue of Sildenafil, in the product. Sildenafil is an FDA-approved drug used in the treatment of Erectile Dysfunction (ED). The analogue may interact with nitrates found in some prescription drugs and lower blood pressure to precarious levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Duro Extend Capsules were sold nationwide. Consumers with Duro Extend Capsules in their possession were advised to stop using them immediately. Intelli Health Products initiated a voluntary recall of the product.  

Other recalls

The True Man, Energy Max, Zencore, Zimaxx, Libidus, Neophase, Nasutra, Actra-Rx, 4EVERON and Encore products are the latest additions to the list of dietary supplements that the FDA has warned consumers against. In July 2006, the agency analyzed 17 products marketed online to treat Erectile Dysfunction and found that many of them contained non-dietary chemicals   .

Preventive measures by law

The U.S. Food and Drug Administration (FDA) issued regulations concerning the implementation of the Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) in 1990 (21 C.F.R. Part 205) and 1999 (21 C.F.R. Part 203). It is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs. The agency can initiate action to remove adulterated and misbranded drugs from the market. To prevent further shipment of an adulterated or misbranded product, the agency may request a federal district court to issue a restraining order against the manufacturer or distributor of the drug.

Policy

The following may invite FDA action:

1. Compounding drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions.
2. Compounding drugs that were withdrawn from the market for safety reasons.
3. Compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs without an FDA sanctioned investigational new drug application (IND) in accordance with 21 U.S.C. § 355(i) and 21 CFR 312.
4. Receiving, storing, or using drug substances without first obtaining a written assurance from the supplier that each lot of the drug substance has been made in an FDA-registered facility.
5. Receiving, storing, or using drug components not guaranteed or otherwise determined to meet offi-cial compendia requirements.
6. Using commercial scale manufacturing or testing equipment for compounding drug products.
7. Compounding drugs for third parties who resell to individual patients or offering compounded drug products on wholesale to other state-licensed persons or commercial entities for resale.
8. Compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products.
9. Failing to operate in conformity with the pharmacy laws of the state.