Libimax Recalled by Nature & Health for Undeclared IngredientsApr 30, 2009 | Parker Waichman LLP Nature & Health Company has issued a voluntary, nationwide recall of its Libimax product, announced the U.S. Food and Drug Administration (FDA). Libimax is marketed as a dietary supplement but was found to contain an active ingredient in an FDA-approved drug.
Nature & Health is located in Brea, California and has been informed by representatives of the FDA that laboratory analysis by the agency of Libimax samples found Libimax to contain tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED). This finding renders Libimax an unapproved drug. The FDA says this finding poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Tadalafil may also cause headaches and flushing, said the FDA.
We have long been reporting on the issue of erectile dysfunction supplements containing undeclared ingredients. This issue is of particular and serious concern because ED is a common problem in men with diabetes, high blood pressure, high cholesterol, or heart disease. These patients are often advised against taking ED drugs and may look for alternative products because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. The use of undeclared chemicals poses a threat to these consumers because they may harmfully interact with nitrates found in some prescription drugs, such as nitroglycerin, and may dangerously lower blood pressure. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates.
Recalled Libimax is sold as a one-capsule individual pack or in 10-capsule and 20-capsule plastic bottles in retail stores in California, Georgia, Illinois, Texas, and Ohio. According to the FDA, the recalled Libimax product label neither states it contains tadalafil nor warns consumers with high blood pressure not to ingest the product.
Consumers who have Libimax in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking the recalled Libimax. The FDA also encourages consumers to submit a report of any serious adverse events that occur with the use of Libimax to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm ]; 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 20852-9787] or fax [1-800-FDA-0178].
The FDA is also advising consumers to return any unused Libimax for a refund of the full purchase price, or the price for the unused portion, to the retail location from where it was purchased or to contact Nature & Health directly at 1-714-257-1800 Monday through Friday, from 8:00 am to 5:00 pm or by email at firstname.lastname@example.org to receive further instructions for returning the product or with any questions.
In one of many similar such situations, last month, we reported that Bodee LLC, Inc. of Century City, California issued a voluntary, nationwide recall of all of its Zencore Tabs, citing an FDA announcement. The recalled Zencore Tabs were marketed as a dietary supplement sold under the name Zencore Tabs. An FDA laboratory analysis by the agency of the Zencore Tabs samples found that the Zencore Tabs analyzed contained a potentially harmful, undeclared active ingredient of an FDA-approved drug, also used to treat ED.