Novacare LLC announced today that it is conducting a voluntary nationwide recall of products sold under the following names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45, and Zilex (with Golden Spear).
Novacare LLC has been informed by representatives of the Food & Drug Administration (FDA) that the products appear to contain sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction. "Sulfoaildenafil" is not declared on the product labels. The undeclared ingredient 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.
The recalled products listed above were distributed in bottles and/or "blister cards" to retailers and via internet sales. All lots of the above-named products with manufacture or distribution dates prior to June 17, 2010 are being recalled.
This recall is being conducted as a precautionary measure. No illnesses or adverse effects have been reported to the company to date in connection with these products.
Customers who have any of the above-named products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking these products.
Consumers and healthcare professionals should report any adverse events that may be related to the use of the above-named products to the FDA's Med Watch Adverse Event Reporting Program online at www.fda.gov/medwatch/report.htm9, 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.htm10 by mail to FDA Med Watch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax to 1-800-FDA-0178.
Novacare LLC is conducting this recall with the knowledge of the FDA. Consumers should return any unused product to the place of purchase or contact Novacare LLC directly at 801-290-1738, Monday – Friday, 10 am to 4 pm MDT.
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Wednesday, August 11, 2010
Novacare LLC Conducts Voluntary Nationwide Recall of Products Found to Contain Undeclared Drug Ingredient
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Tuesday, July 14, 2009
Haloteco Issues A Voluntary Nationwide Recall of Libipower Plus, a Product Marketed as a Dietary Supplement
Haloteco announced today that it is conducting a nationwide voluntary recall of the company's product sold under the name Libipower Plus.
Haloteco is conducting this recall after being informed by the representative of the Food and Drug Administration (FDA) that lab analysis of Libipower Plus samples found that the product contained Tadalalafil which is the active ingredient of FDA approved drugs for Erectile Dysfunction (ED). The product label doesn’t states it contain tadalafil. The undeclared ingredients 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. Additionally, the product may cause side effects, such as headaches and flushing.
Libipower Plus is sold as a 1 capsule blister pack through distributors and retail stores in California.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Any adverse events that may be related to the use of this product should be reported to 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 Haloteco Monday through Friday 8:00 am to 5:00 pm at (213) 820-9523. Haloteco is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. Haloteco is working closely with the FDA in the recall process. It sincerely regrets any inconvenience to consumers.
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Wednesday, April 29, 2009
Nature & Health Co. Issues Voluntary Nationwide Recall of Libimax, a Product Marketed as a Dietary Supplement
Nature & Health Co., located in Brea, California, announced today that it is conducting a voluntary nationwide recall of the company's supplement product sold under the name Libimax. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Libimax samples found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making Libimax an unapproved drug. FDA advised that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that tadalafil, may cause side effects, such as headaches and flushing.
The recalled Libimax is sold as a 1 capsule individual pack or 10-capsule and 20-capsule plastic bottles in retail stores in California, Georgia, Illinois, Texas, and Ohio. The 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 this product. The public is encouraged 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].
Nature & Health Co. is committed to providing accurate information about its products because of concern for the health and safety of consumers. Nature & Health Co. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
No illnesses have been reported to the Company to date in connection with this product.
Consumers should return any unused Libimax, for a refund of the full purchase price or price for the unused portion, to the retail location where it was purchased or to contact Nature & Health directly at (714) 257-1800 Monday – Friday, 8am to 5pm or by email at sales@naturenhealth.com to receive further instructions for returning the product or with any questions.
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Tuesday, July 29, 2008
EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient
EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. FDA asserts that this ingredient is an analog of sildenafil. Sildenafil is the active chemical ingredient of an FDA-approved drug used for Erectile Dysfunction (ED) in men to enhance sexual performance.
The use of undeclared chemicals pose a threat to consumers because they may harmfully 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 such nitrates.
Viapro capsules were sold in retail outlets nationwide and were packaged into 2-capsule blister, 1 capsule blister and 10 capsule bottles. Viapro has not been sold since about March 2008.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Please return the product for a full refund to the address below.
Seaboard Tampa Terminal: 6708 Harney Road Tampa Florida, 33610
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, or online.
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