Keime Inc. voluntarily recalled one lot of its dietary supplement product sold under the name Virility Max, on Nov 10, 2011. The lot number of the recalled batch is Lot 10090571. The recall came after FDA lab analysis found Sulfoaildenafil, which is similar to Sildenafil, in the above mentioned lot of Virility Max.

FDA representatives informed the company about this fault. Sildenafil is an active ingredient of Viagra and similar drugs, which are FDA-approved drugs for erectile dysfunction (ED). Practitioners might consider using the lot of Virility Max for ED, as it has the same ingredients that are used in prescription drugs for ED. Since the dietary supplement has not been approved by FDA to be used in this manner, it is considered as unapproved product. Sildenafil which is an active ingredient in the said lot of drug, is not even mentioned on the label of the drug.

Virility Max is a drug for sexual enhancement.  It comes in white plastic bottles for retail sales. There were no reports of any severe side effects related to use of Virility Max. After the faulty batch was discovered, patients were asked to stop using this drug and consult their doctor in case of any unusual or side effect.

The active ingredient Sildenafil could interact with nitrates. If taken with other drugs, which contain nitrates or nitroglycerin, it could yield fatal results. It could cause dangerously low blood pressure. Patients having diabetes , high blood pressure, heart diseases or high cholesterol usually take drugs having nitrates. Therefore, if these patients take Virility Max, it could be dangerous for them.

FDA also asked patients and doctors to report any adverse event or case of severe side effect to FDA’s Med Watch Adverse Event Reporting Program. Patients and doctors could mail, fax or report these events on internet.

Keime Inc. stated that this product was not manufactured by Keime Inc., which is a Florida Corporation. It informed that the particular product was purchased from other vendors and the company voluntarily recalled the faulty lot of drug and is co-operating fully with FDA. The statement said that the company is fully committed to provide accurate information about its products. The company is concerned for the health and safety of consumers. The company stated that it regrets inconvenience to patients and doctors both. It asked patients to return unused drug packs to retail location where the drug was purchased. They could also directly contact the company.

Keime Inc. markets the Virility Max in U.S.  It also operates with the name of Barry’s Vitamins, to do business. Keime Inc. issued a press release to announce the recall of Lot 10090571 Virility Max. the press release stated that Virility Max was distributed only in southern Florida and only in white plastic bottles. There are many products sold online, with the name of Virility Max, which are not marketed by them. None of these namesake drugs come in white plastic bottles. The company has not given any clear description to find out, which of the Virility Max available online is the original one. FDA too has not provided any information regarding this matter.

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